Publications by authors named "Mayank A Nanavaty"

72 Publications

Descemet membrane suturing to manage recurrent graft detachment in a patient with Descemet membrane endothelial keratoplasty on failed penetrating keratoplasty.

Ther Adv Ophthalmol 2021 Jan-Dec;13:25158414211027705. Epub 2021 Jul 6.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Eastern Road, Brighton BN2 5BF, UK.

A 65-year-old patient with history of keratoconus, mild cataract and penetrating keratoplasty over 30 years ago developed corneal oedema subsequent of graft failure with best corrected visual acuity (BCVA) of counting fingers. He underwent a successful cataract surgery combined with a 7.25 mm Descemet's Membrane Endothelial Keratoplasty (DMEK) with Sodium Hexafluoride (SF6) gas. His cornea remained oedematous inferiorly at 4 weeks, despite two subsequent re-bubbling due to persistent DMEK detachment inferiorly. This was managed by three radial full thickness 10-0 nylon sutures placed in the inferior cornea along with intracameral injection of air. Following this, his anterior segment ocular coherence tomography (OCT) confirmed complete attachment of the graft, and the sutures were removed 4 weeks later. Unaided visual acuity was 20/63 and BCVA was 20/32 after 8 months. DMEK suturing can be helpful in persistent DMEK detachments, which is refractory to repeated re-bubbling due to uneven posterior surface of previous PK.
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http://dx.doi.org/10.1177/25158414211027705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8264843PMC
July 2021

Cost-effective and adaptable cataract surgery simulation with basic technology.

Eye (Lond) 2021 Jun 25. Epub 2021 Jun 25.

Singleton Hospital, Sketty, UK.

Purpose: To assess the subjective validity of a cost-effective and adaptable cataract surgery simulation technique using basic technology.

Methods: We devised and filmed a range of simulation techniques that mimic steps of phacoemulsification cataract surgery using various "everyday" basic materials. This video was combined in a "parallel" fashion with live cataract surgery so that all steps of surgery were simulated. Subsequently, we distributed an online subjective validation questionnaire on Google Forms with the embedded simulation video in a generic invitation that was forwarded via email and/or text messages/WhatsApp messenger amongst Ophthalmologists of all grades within our regions (Kent, Surrey and Sussex, London and Wales Postgraduate Deaneries).

Results: Face validity: 66 (99%) participants agreed that the explanations in the video were clear and 53 (79%) concurred with the realistic feel of simulated technique. Instrumentation and adaptations demonstrated were deemed user friendly and conducive to replicate by 99% participants. Content validity: 60 (90%) of participants agreed the techniques described in the video reflected the technical skills required to train cataract surgeons. Forty-nine (74%) agreed that the simulation techniques were relevant for acquiring other generic and transferable microsurgical and manual dexterity skills.

Conclusions: We demonstrated subjective validity of our cost-effective cataract simulation technique. Our model can be used as an adjunct to intraocular and virtual reality training for cataract surgery by removing the barrier of cost and improved exposure to real instruments used in cataract surgery.
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http://dx.doi.org/10.1038/s41433-021-01644-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8227359PMC
June 2021

Recurring themes during cataract assessment and surgery.

Eye (Lond) 2021 09 29;35(9):2482-2498. Epub 2021 Apr 29.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.

The aim of this review was to discuss frequently encountered themes such as cataract surgery in presence of age-related macular degeneration (AMD), dementia, Immediate Sequential Bilateral Cataract Surgery (ISBCS), discussing non-standard intraocular lens (IOL) options during consultation in the National Health Services (NHS) and the choice of the biometric formulae based on axial length. Individual groups of authors worked independently on each topic. We found that cataract surgery does improve visual acuity in AMD patients but the need for cataract surgery should be individualised. In patients with dementia, cataract surgery should be considered 'sooner rather than later' as progression may prevent individuals presenting for surgery. This should be planned after discussion of patients' best interests with any carers; multifocal IOLs are not proven to be the best option in these patients. ISBCS gives comparable outcomes to delayed sequential surgeries with a low risk of bilateral endophthalmitis and it can be cost-saving and efficient. Patients are entitled to know all suitable IOL options that can improve their quality of life. Deliberately withholding this information or pressuring patients to choose a non-standard IOL is inappropriate. However, one should be mindful of the not spending inappropriate amounts of time discussing these in the NHS setting which may affect care of other NHS patients. Evidence suggests Hoffer Q, Haigis, Hill-RBF and Kane formulae for shorter eyes; Barrett Universal II (BU II), Holladay II, Haigis and Kane formulae for longer eyes and BU II, Hill-RBF and Kane formulae for medium axial length eyes.
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http://dx.doi.org/10.1038/s41433-021-01548-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376990PMC
September 2021

Validity of scoring systems for the assessment of technical and non-technical skills in ophthalmic surgery-a systematic review.

Eye (Lond) 2021 Jul 1;35(7):1833-1849. Epub 2021 Mar 1.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.

Evaluation and recommendation of the scoring systems for technical skills (TS) and non-technical skills (NTS) assessments in ophthalmic surgery. A literature search was performed between December 2019 and May 2020. Studies describing the development or validation of TS or NTS scoring systems in ophthalmic surgery were included. Only scoring systems for completion by hand were included. The primary outcome was the validity and reliability status for each scoring system. The secondary outcome was recommendation based on modified Oxford Centre for Evidence-Based Medicine guidelines. Nineteen and five scoring systems were identified for TS and NTS respectively. TS scoring systems exist for cataract surgery (including the steps of phacoemulsification and paediatric cataract surgery) ptosis, strabismus, lateral tarsal strip, vitrectomy, and intraocular surgery in general. NTS scoring systems apply to cataract surgery or ophthalmic surgery in general. No single scoring system satisfied all validity and reliability measures. The recommended TS scoring systems are 'International Council of Ophthalmology's Ophthalmology Surgical Competency Assessment Rubrics' (ICO-OSCAR) for phacoemulsification, strabismus and paediatric cataract surgery, and 'Objective Structured Assessment of Cataract Surgical Skill' (OSACSS). Non-Technical Skills for Surgeons (NOTSS), Observational Teamwork Assessment for Surgery (OTAS) and Anaesthetists Non-Technical Skills (ANTS) are recommended for NTS. There is a paucity of NTS scoring systems. Further research is required to validate all scoring systems to consistent standards. Limitations of the assessment tools included infrequent quantification of face and content validity, and inconsistency in terminology and statistical methods between studies.
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http://dx.doi.org/10.1038/s41433-021-01463-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8225616PMC
July 2021

Re-Endothelialization of Bare Stroma after Descemet's Detachment due to Macroperforation during Deep Anterior Lamellar Keratoplasty.

J Curr Ophthalmol 2020 Oct-Dec;32(4):423-426. Epub 2020 Dec 12.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.

Purpose: To report a case with spontaneous re-endothelialization of bare stroma after subtotal detachment of Descemet's membrane (DM) due to macroperforation during deep anterior lamellar keratoplasty (DALK).

Methods: Case report.

Results: A 64-year-old patient underwent DALK for deep stromal scarring secondary to herpetic keratitis. During manual dissection, DM macroperforation occurred, and this was successfully managed intraoperatively and postoperatively. The DM with host posterior stroma remained attached for 10 months when it detached from the bare donor stroma. The cornea remained clear, with uncorrected distance visual acuity (UCVA) of 0.17 logMAR. After graft suture removal 30 months later, he was noted to have regular astigmatism and cataract for which he underwent phacoemulsification with toric intraocular lens implantation. Twenty-four months following his cataract surgery and 58 months following his DALK, his UCVA remains 0.17 logMAR and the cornea remains clear with no evidence of edema. His average specular count at 58 months was 1296 cell/mm .

Conclusion: This case shows a very good visual outcome with clear cornea at 58 months despite of large DM detachment which happened 10 months following manual DALK with intraoperative macroperforation.
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http://dx.doi.org/10.4103/JOCO.JOCO_79_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7861102PMC
December 2020

Femtosecond laser-assisted cataract surgery compared with phacoemulsification: the FACT non-inferiority RCT.

Health Technol Assess 2021 Jan;25(6):1-68

The National Institute for Health Research (NIHR) Biomedical Research Centre, Moorfields Eye Hospital NHS Foundation Trust, London, UK.

Background: Cataract surgery is one of the most common operations. Femtosecond laser-assisted cataract surgery (FLACS) is a technique that automates a number of operative steps.

Objectives: To compare FLACS with phacoemulsification cataract surgery (PCS).

Design: Multicentre, outcome-masked, randomised controlled non-inferiority trial.

Setting: Three collaborating NHS hospitals.

Participants: A total of 785 patients with age-related cataract in one or both eyes were randomised between May 2015 and September 2017.

Intervention: FLACS ( = 392 participants) or PCS ( = 393 participants).

Main Outcome Measures: The primary outcome was uncorrected distance visual acuity in the study eye after 3 months, expressed as the logarithm of the minimum angle of resolution (logMAR): 0.00 logMAR (or 6/6 if expressed in Snellen) is normal (good visual acuity). Secondary outcomes included corrected distance visual acuity, refractive outcomes (within 0.5 dioptre and 1.0 dioptre of target), safety and patient-reported outcome measures at 3 and 12 months, and resource use. All trial follow-ups were performed by optometrists who were masked to the trial intervention.

Results: A total of 353 (90%) participants allocated to the FLACS arm and 317 (81%) participants allocated to the PCS arm attended follow-up at 3 months. The mean uncorrected distance visual acuity was similar in both treatment arms [0.13 logMAR, standard deviation 0.23 logMAR, for FLACS, vs. 0.14 logMAR, standard deviation 0.27 logMAR, for PCS, with a difference of -0.01 logMAR (95% confidence interval -0.05 to 0.03 logMAR;  = 0.63)]. The mean corrected distance visual acuity values were again similar in both treatment arms (-0.01 logMAR, standard deviation 0.19 logMAR FLACS vs. 0.01 logMAR, standard deviation 0.21 logMAR PCS;  = 0.34). There were two posterior capsule tears in the PCS arm. There were no significant differences between the treatment arms for any secondary outcome at 3 months. At 12 months, the mean uncorrected distance visual acuity was 0.14 logMAR (standard deviation 0.22 logMAR) for FLACS and 0.17 logMAR (standard deviation 0.25 logMAR) for PCS, with a difference between the treatment arms of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR;  = 0.17). The mean corrected distance visual acuity was 0.003 logMAR (standard deviation 0.18 logMAR) for FLACS and 0.03 logMAR (standard deviation 0.23 logMAR) for PCS, with a difference of -0.03 logMAR (95% confidence interval -0.06 to 0.01 logMAR;  = 0.11). There were no significant differences between the arms for any other outcomes, with the exception of the mean binocular corrected distance visual acuity with a difference of -0.02 logMAR (95% confidence interval -0.05 to 0.00 logMAR) ( = 0.036), which favoured FLACS. There were no significant differences between the arms for any health, social care or societal costs. For the economic evaluation, the mean cost difference was £167.62 per patient higher for FLACS (95% of iterations between -£14.12 and £341.67) than for PCS. The mean QALY difference (FLACS minus PCS) was 0.001 (95% of iterations between -0.011 and 0.015), which equates to an incremental cost-effectiveness ratio (cost difference divided by QALY difference) of £167,620.

Limitations: Although the measurement of outcomes was carried out by optometrists who were masked to the treatment arm, the participants were not masked.

Conclusions: The evidence suggests that FLACS is not inferior to PCS in terms of vision after 3 months' follow-up, and there were no significant differences in patient-reported health and safety outcomes after 12 months' follow-up. In addition, the statistically significant difference in binocular corrected distance visual acuity was not clinically significant. FLACS is not cost-effective.

Future Work: To explore the possible differences in vision in patients without ocular co-pathology.

Trial Registration: Current Controlled Trials ISRCTN77602616.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 6. See the NIHR Journals Library website for further project information. Moorfields Eye Charity (grant references GR000233 and GR000449 for the endothelial cell counter and femtosecond laser used).
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http://dx.doi.org/10.3310/hta25060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883211PMC
January 2021

Scanning Electron Microscopic of Intraocular Lens Pits after Nd:YAG Capsulotomy.

Ophthalmology 2020 11;127(11):1538

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, United Kingdom.

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http://dx.doi.org/10.1016/j.ophtha.2020.07.002DOI Listing
November 2020

Comparison of intraocular lens calculation methods after myopic laser-assisted in situ keratomileusis and radial keratotomy without prior refractive data.

Br J Ophthalmol 2020 Oct 22. Epub 2020 Oct 22.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK

Aim: To compare intraocular lens (IOL) calculation methods not requiring refraction data prior to myopic laser-assisted in situ keratomileusis (LASIK) and radial keratotomy (RK).

Methods: In post-LASIK eyes, the methods not requiring prior refraction data were Hagis-L; Shammas; Barrett True-K no-history; Wang-Koch-Maloney; 'average', 'minimum' and 'maximum' IOL power on the American Society of Cataract and Refractive Surgeons (ASCRS) IOL calculator. Double-K method and Barrett True-K no-history, 'average', 'minimum' and 'maximum' IOL power on ASCRS IOL calculator were evaluated in post-RK eyes. The predicted IOL power was calculated with each method using the manifest postoperative refraction. Arithmetic and absolute IOL prediction errors (PE) (implanted-predicted IOL powers), variances in arithmetic IOL PE and percentage of eyes within ±0.50 and ±1.00 D of refractive PE were calculated.

Results: Arithmetic or absolute IOL PE were not significantly different between the methods in post-LASIK and post-RK eyes. In post-LASIK eyes, 'average' showed the highest and 'minimum' showed the least variance, whereas 'average' and 'minimum' had highest percentage of eyes within ±0.5 D and 'minimum' had the highest percentage of eyes within ±1.0 D. In the post-RK eyes, 'minimum' had highest variance, and 'average' had the least variance and highest percentage of eyes within ±0.5 D and ±1.0 D.

Conclusion: In post-LASIK and post-RK eyes, there are no significant differences in IOL PE between the methods not requiring prior refraction data. 'Minimum' showed least variance in PEs and more chances of eyes to be within ±1.0 D postoperatively in post-LASIK eyes. 'Average' had least variance and more chance of eyes within ±1.0 D in post-RK eyes.
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http://dx.doi.org/10.1136/bjophthalmol-2020-317681DOI Listing
October 2020

Reply.

J Cataract Refract Surg 2020 10;46(10):1448-1450

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http://dx.doi.org/10.1097/j.jcrs.0000000000000383DOI Listing
October 2020

Aerosol generation through pars plana vitrectomy.

Br J Ophthalmol 2021 09 14;105(9):1313-1317. Epub 2020 Oct 14.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK

Purpose: To assess whether pars plana vitrectomy (PPV) is an aerosol-generating procedure (AGP) in an ex vivo experimental model.

Methods: In this ex vivo study on 10 porcine eyes, optical particle counter was used to measure particles ≤10 μm using cumulative mode in the six in-built channels: 0.3 μm, 0.5 μm, 1 μm, 2.5 μm, 5 μm and 10 μm aerosols during PPV. Two parts of the study were as follows: (1) to assess the pre-experimental baseline aerosol count in the theatre environment where there are dynamic changes in temperature and humidity and (2) to measure aerosol generation with 23-gauge and 25-gauge set-up. For each porcine eye, five measurements were taken for each consecutive step in the experiment including pre-PPV, during PPV, fluid-air exchange (FAX) and venting using a flute with 23-gauge set-up and a chimney with 25-gauge set-up. Therefore, a total of 200 measurements were recorded.

Results: With 23-gauge and 25-gauge PPV, there was no significant difference in aerosol generation in all six channels comparing pre-PPV versus PPV or pre-PPV versus FAX. Venting using flute with 23-gauge PPV showed significant reduction of aerosol ≤1 μm. Air venting using chimney with 25-gauge set-up showed no significant difference in aerosol of ≤1 μm. For cumulative aerosol counts of all particles measuring ≤5 μm, compared with pre-PPV, PPV or FAX, flute venting in 23-gauge set-up showed significant reduction unlike the same comparison for chimney venting in 25-gauge set-up.

Conclusion: PPV and its associate steps do not generate aerosols ≤10 μm with 23-gauge and 25-gauge set-ups.
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http://dx.doi.org/10.1136/bjophthalmol-2020-317214DOI Listing
September 2021

Autoimmune Dry Eye without Significant Ocular Surface Co-Morbidities and Mental Health.

Vision (Basel) 2020 Oct 10;4(4). Epub 2020 Oct 10.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton BN2 5BF, UK.

Dry eye symptoms can negatively affect the psychological, physical, and social functioning, which can potentially impair the health-related quality of life. This review evaluated the association between autoimmune related dry eye in the absence of significant ocular surface co-morbidities and mental health. This review found a significantly higher prevalence of mental health disorders (such as depression and anxiety) in systemic lupus erythematous, rheumatoid arthritis, systemic sclerosis, Behcet's disease, and primary Sjogren's syndrome patients when compared to the general population. Moreover, patients with depression and anxiety interpret ocular sensations differently than healthy controls and the perception of dry eye symptoms can be influenced by their mood. Somatization is common in depression, and this could influence the perception of ocular discomfort. Anti-depressants and anxiolytics with their potential side effects on the tear film status may also contribute or aggravate the dry eye symptoms in these patients. Although ophthalmologists manage the dry eye disease, as per standardized algorithms, they should be mindful of different ocular sensation interpretation and coexistent mental health issues in a large number of this patient group and initiate a multidisciplinary management plan in certain cases. While rheumatologists look after their autoimmune condition, it may be worth liaising with GP and/or psychiatrist colleagues in order to address their neuropathic type pain and mental health co-morbidities.
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http://dx.doi.org/10.3390/vision4040043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7711510PMC
October 2020

Effect of Intraocular Lens Tilt and Decentration on Visual Acuity, Dysphotopsia and Wavefront Aberrations.

Vision (Basel) 2020 Sep 14;4(3). Epub 2020 Sep 14.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton BN2 5BF, UK.

Tilt and decentration of intraocular lenses (IOL) may occur secondary to a complicated cataract surgery or following an uneventful phacoemulsification. Although up to 2-3° tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed for any design of IOL, larger extent of tilt and decentration has a negative impact on the optical performance and subsequently, the patients' satisfaction. This negative impact does not affect various types of IOLs equally. In this paper we review the methods of measuring IOL tilt and decentration and focus on the effect of IOL tilt and decentration on visual function, in particular visual acuity, dysphotopsia, and wavefront aberrations. Our review found that the methods to measure the IOL displacement have significantly evolved and the available studies have employed different methods in their measurement, while comparability of these methods is questionable. There has been no universal reference point and axis to measure the IOL displacement between different studies. A remarkably high variety and brands of IOLs are used in various studies and occasionally, opposite results are noticed when two different brands of a same design were compared against another IOL design in two studies. We conclude that <5° of inferotemporal tilt is common in both crystalline lenses and IOLs with a correlation between pre- and postoperative lens tilt. IOL tilt has been noticed more frequently with scleral fixated compared with in-the-bag IOLs. IOL decentration has a greater impact than tilt on reduction of visual acuity. There was no correlation between IOL tilt and decentration and dysphotopsia. The advantages of aspheric IOLs are lost when decentration is >0.5 mm. The effect of IOL displacement on visual function is more pronounced in aberration correcting IOLs compared to spherical and standard non-aberration correcting aspherical IOLs and in multifocal versus monofocal IOLs. Internal coma has been frequently associated with IOL tilt and decentration, and this increases with pupil size. There is no correlation between spherical aberration and IOL tilt or decentration. Although IOL tilt produces significant impact on visual outcome in toric IOLs, these lenses are more sensitive to rotation compared to tilt.
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http://dx.doi.org/10.3390/vision4030041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559075PMC
September 2020

Comparison of Optical Low-Coherence Reflectometry and Swept-Source OCT-Based Biometry Devices in Dense Cataracts.

J Refract Surg 2020 Aug;36(8):557-564

Purpose: To investigate agreement between biometric measurements obtained from the Lenstar LS 900 (Haag-Streit AG) based on optical low-coherence reflectometry (OLCR) and the Tomey OA-2000 (Tomey Corporation) based on swept-source optical coherence tomography (SS-OCT) in dense cataracts.

Methods: In this prospective observational study, axial length, keratometry, anterior chamber depth (ACD), lens thickness, and central corneal thickness (CCT) were measured in 124 eyes of 76 patients. Intraocular lens prediction errors and absolute prediction errors were assessed based on postoperative manifest refraction. Analyses used were paired t test, Pearson correlation coefficient (r), and Bland-Altman plots.

Results: Failure in axial length measurements was noted in 28 eyes (22.58%) with OCLR compared to 2 eyes (1.6%) with SS-OCT. Although not statistically significant, axial length measurements were clinically higher with SS-OCT (23.78 ± 1.76 mm) compared to OCLR (23.72 ± 1.58 mm) (P = .81) (r = 0.23; P = .01). There was a significant trend toward myopic intraocular lens prediction with SS-OCT (-0.09 ± 0.48) compared to OLCR (0.09 ± 0.41, P < .01) (r = 0.25, P = .01). There was good agreement for keratometric and ACD values between the two devices. SS-OCT gave significantly higher values of lens thickness compared to OCLR (4.44 ± 0.44 vs 4.18 ± 0.48 mm, P < .01) (r = 0.39, P < .01). CCT measured with OCLR was significantly higher than SS-OCT (525.64 ± 27.0 vs 513.21 ± 29.24 µm; P < .01) (r = 0.98, P < .01).

Conclusions: One-fifth of the patients with dense cataracts failed axial length measurement on OCLR. SS-OCT gives clinically higher axial length measurements leading to more myopic intraocular lens prediction errors postoperatively. OCLR provides higher pachymetry and lower lens thickness values compared to the SS-OCT device. [J Refract Surg. 2020;36(8):557-564.].
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http://dx.doi.org/10.3928/1081597X-20200612-03DOI Listing
August 2020

Femtosecond laser-assisted cataract surgery compared with phacoemulsification cataract surgery: randomized noninferiority trial with 1-year outcomes.

J Cataract Refract Surg 2020 Oct;46(10):1360-1367

From the NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust (Day, Wilkins), London, Moorfields Eye Hospital (Day, Wilkins), London, UCL Institute of Ophthalmology (Day), London, School of Medicine, University of St. Andrews (Burr), St. Andrews, UCL Comprehensive Clinical Trials Unit (Bennett, Dore, Hunter), London, Department of Primary Care & Public Health Sciences, King's College London (Bunce), London, Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Nanavaty), Brighton, Wolverhampton and Midlands Eye Infirmary, New Cross Hospital, Royal Wolverhampton NHS Trust (Balaggan), Wolverhampton, United Kingdom.

Purpose: To report the 1-year outcomes of a randomized trial comparing femtosecond laser-assisted cataract surgery (FLACS) and phacoemulsification cataract surgery (PCS).

Setting: Moorfields Eye Hospital, New Cross Hospital, and Sussex Eye Hospital, United Kingdom.

Design: Multicenter, randomized controlled noninferiority trial.

Methods: Patients undergoing cataract surgery were randomized to FLACS or PCS. Postoperative assessments were masked. Outcomes included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), complications, corneal endothelial cell count, and patient-reported outcomes measures.

Results: The study enrolled 785 participants. A total of 311 of 392 (79%) participants were allocated to FLACS and 292 of 393 (74%) participants were allocated to PCS attended follow-up at 1 year. Mean UDVA was 0.14 (SD = 0.22) for FLACS and 0.17 (0.25) for PCS with difference of -0.03 logarithm of the minimum angle of resolution (logMAR) (95%, -0.06 to 0.01, P = .17). Mean CDVA was 0.003 (0.18) for FLACS and 0.03 (0.23) for PCS with difference of -0.03 logMAR (95% CI, -0.06 to 0.01, P = .11); 75% of both FLACS (230/307) and PCS (218/290) cases were within ±0.5 diopters (D) refractive target, and 292 (95%) of 307 eyes of FLACS and 279 (96%) of 290 eyes of PCS groups were within ±1.0 D. There were no significant differences between arms for all other outcomes with the exception of binocular CDVA mean difference -0.02 (-0.05 to 0.002) logMAR (P = .036) favoring FLACS. Mean cost difference was £167.62 per patient greater for FLACS (95% iterations between -£14.12 and £341.67).

Conclusions: PCS is not inferior to FLACS regarding vision, patient-reported health, and safety outcomes after 1-year follow-up. A difference was found for binocular CDVA, which, although statistically significant, was not clinically important. FLACS was not cost-effective.
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http://dx.doi.org/10.1097/j.jcrs.0000000000000257DOI Listing
October 2020

Aerosol generation through phacoemulsification.

J Cataract Refract Surg 2020 09;46(9):1290-1296

From the Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Lee, Naveed, Ashena, Nanavaty), and Brighton & Sussex Medical School, University of Sussex (Naveed, Nanavaty), Brighton, United Kingdom.

Purpose: To evaluate whether phacoemulsification is an aerosol-generating procedure in an ex vivo experimental model.

Setting: Sussex Eye Hospital, Brighton, United Kingdom.

Design: Experimental study.

Methods: In this ex vivo study on 15 porcine eyes, an optical particle counter was used to measure particles of 10 µm and less using the cumulative mode based on the 6 in-built channel sizes. The 2 parts of the study were to: (1) assess the efficacy of the particle counter in the theater environment where there are dynamic changes in temperature and humidity; and (2) to measure aerosol generation with 3 phacoemulsification settings: (i) continuous power with 80% longitudinal (5 eyes); (ii) continuous power with 100% torsional (5 eyes); and (iii) continuous power with 80% longitudinal with application of hydroxypropyl methylcellulose (HPMC) on the ocular surface (5 eyes). Five measurements were taken prephacoemulsification and 5 during phacoemulsification per eye therefore totaling 75 measurements.

Results: Maximum aerosols were captured when the counter faced the aerosol source. There was no significant difference in aerosol generation of all sizes during each phacoemulsification setting with torsional, longitudinal, and longitudinal with HPMC (P > .01). Combining data of all 3 phacoemulsification settings (150 measurements from 15 eyes), there was no significant difference comparing prephacoemulsification and during phacoemulsification for aerosols of 5 µm or less (1455 vs 1363.85, P = .60), more than 5 to 10 μm (1.5 vs 1.03, P = .43), and of 10 µm or less (1209 vs 1131.55, P = .60).

Conclusions: Phacoemulsification did not generate aerosols of 10 μm or less with continuous power using 80% longitudinal, 100% torsional, and 80% longitudinal setting with HPMC on the surface.
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http://dx.doi.org/10.1097/j.jcrs.0000000000000288DOI Listing
September 2020

'Face down' anterior vitrectomy for unexpected posterior capsule rupture as an alternative to pars plana vitrectomy.

Eye (Lond) 2021 05 28;35(5):1515-1517. Epub 2020 May 28.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.

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http://dx.doi.org/10.1038/s41433-020-0985-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182825PMC
May 2021

Femtosecond Laser-Assisted Cataract Surgery Versus Phacoemulsification Cataract Surgery (FACT): A Randomized Noninferiority Trial.

Ophthalmology 2020 08 3;127(8):1012-1019. Epub 2020 Mar 3.

The NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom; Moorfields Eye Hospital, London, United Kingdom.

Purpose: To report the 3-month results of a randomized trial (Femtosecond Laser-Assisted Cataract Trial [FACT]) comparing femtosecond laser-assisted cataract surgery (FLACS) with standard phacoemulsification cataract surgery (PCS).

Design: Multicenter, randomized controlled trial funded by the UK National Institute of Health Research (HTA 13/04/46/).

Participants: Seven hundred eighty-five patients with age-related cataract.

Methods: This trial took place in 3 hospitals in the UK National Health Service (NHS). Randomization (1:1) was stratified by site, surgeon, and 1 or both eyes eligible using a secure web-based system. Postoperative assessments were masked to the allocated intervention. The primary outcome was unaided distance visual acuity (UDVA) in the study eye at 3 months. Secondary outcomes included corrected distance visual acuity, complications, and patient-reported outcomes measures. The noninferiority margin was 0.1 logarithm of the minimum angle of resolution (logMAR). ISRCTN.com registry, number ISRCTN77602616.

Main Outcome Measures: We enrolled 785 participants between May 2015 and September 2017 and randomly assigned 392 to FLACS and 393 to PCS. At 3 months postoperatively, mean UDVA difference between treatment arms was -0.01 logMAR (-0.05 to 0.03), and mean corrected distance visual acuity difference was -0.01 logMAR (95% confidence interval [CI], -0.05 to 0.02). Seventy-one percent of both FLACS and PCS cases were within ±0.5 diopters (D) of the refractive target, and 93% of FLACS and 92% of PCS cases were within ±1.0 D. There were 2 posterior capsule tears in the PCS arm and none in the FLACS arm. There were no significant differences between arms for any secondary outcome.

Conclusions: Femtosecond laser-assisted cataract surgery is not inferior to conventional PCS surgery 3 months after surgery. Both methods are as good in terms of vision, patient-reported health, and safety outcomes at 3 months. Longer-term outcomes of the clinical effectiveness and cost-effectiveness are awaited.
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http://dx.doi.org/10.1016/j.ophtha.2020.02.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397499PMC
August 2020

Delayed Onset Scleromalacia and Conjunctival Bleb Formation Following Intraoperative Mitomycin C Application during Conjunctival Melanoma Excision.

Vision (Basel) 2020 May 6;4(2). Epub 2020 May 6.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton BN2 5BF, UK.

Purpose: To present a case of delayed onset scleromalacia and conjunctival bleb formation one year after conjunctival melanoma excision with intraoperative use of mitomycin-C (MMC) and double-freeze-thaw technique.

Methods: Case report.

Results: A 69-year-old woman had a conjunctival melanoma excised by the 'no touch technique' with intraoperative application of 0.02% MMC for 3 min on bare sclera, freeze-thaw cryotherapy and amniotic membrane transplant performed elsewhere. Three months later, she presented to us with a red, sore and painful right eye. Examination revealed severe scleritis. She was treated with lubricants and oral steroids for 6 weeks. She settled well with no recurrence of melanoma. At one year, she developed scleromalacia and conjunctival blebs in the inferonasal quadrant of right eye. She remains under closer observation as she is at high risk of perforation.

Conclusion: Caution should be exercised with intraoperative use of MMC on bare sclera during excision and cryotherapy of conjunctival melanoma. As published in the literature, when using MMC, it is recommended to use the lowest dose topically in the form of eye drops in the postoperative period for the shortest time to avoid any sight-threatening complications.
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http://dx.doi.org/10.3390/vision4020024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356894PMC
May 2020

Development of the HUman Factors in intraoperative Ophthalmic Emergencies Scoring System (HUFOES) for non-technical skills in cataract surgery.

Eye (Lond) 2021 02 5;35(2):616-624. Epub 2020 May 5.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.

Background: Nontechnical skills (NTS) are fundamental for successfully managing intraoperative complications. We aimed to develop the HUman Factors in intraoperative Ophthalmic Emergencies Scoring System (HUFOES); an NTS assessment system for posterior capsule rupture (PCR) during cataract surgery.

Methods: A literature review and a focus group consisting of three cataract surgeons and one NTS researcher elicited the important NTS for the management of intraoperative cataract surgery complications. A novel taxonomy of NTS specific for PCR management was generated. Questionnaires were distributed to ophthalmologists in one UK training region. Delphi methodology was used to develop a final HUFOES draft. One further questionnaire was used to gain feasibility, educational impact and validity data.

Results: All HUFOES components achieved a mean importance rating of >8/10 and achieved high interrater agreement ratings (α = 0.953). Interrater agreement scores for HUFOES categories were: teamwork and communication (α = 0.819), leadership (α = 0.859), decision making (α = 0.753), situational awareness (α = 0.840) and professionalism (α = 0.890). In all, 92.8% (n = 13) rated HUFOES as specific for use, 85.7% (n = 12) agreed it contains appropriate assessment measures, 92.8% (n = 13) agreed that training with HUFOES would enhance preparation for PCR management and 78.6% (n = 11) declared HUFOES as the preferable training system for NTS in intraoperative ophthalmic emergencies when compared with the current gold standard.

Conclusions: HUFOES has been developed and validated as a tool for the training and assessment of NTS in PCR. An NTS training programme integrated with HUFOES should be considered in order to enhance surgical NTS for managing intraoperative complications, and improve performance and outcomes following PCR.
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http://dx.doi.org/10.1038/s41433-020-0921-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8027445PMC
February 2021

Controversies regarding mask usage in ophthalmic units in the United Kingdom during the COVID-19 pandemic.

Eye (Lond) 2020 Jul 23;34(7):1172-1174. Epub 2020 Apr 23.

Sussex Eye Hospital, Brighton and Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.

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http://dx.doi.org/10.1038/s41433-020-0892-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7179380PMC
July 2020

Refractive lens exchange with a trifocal intraocular lens in Fuchs endothelial dystrophy.

J Cataract Refract Surg 2020 03;46(3):478-481

From the Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust (Nanavaty, Ashena), and Brighton & Sussex Medical School, University of Sussex (Nanavaty), Falmer, Brighton, United Kingdom.

A 57-year-old man with myopia presented with advanced Fuchs endothelial dystrophy, a refraction of -6.00 diopters (D) and -6.25 D, an endothelial cell count of 1100 cells/mm and 1000 cells/mm in right and left eyes, respectively, and corrected distance visual acuity of 20/30 in each eye. The patient was deemed unsuitable for excimer or femtosecond laser-based refractive surgery or refractive lens exchange (RLE) with a trifocal intraocular lens (IOL) alone because of the advanced Fuchs endothelial dystrophy and high risk of corneal decompensation and reduced optical quality postoperatively. A successful RLE with a hydrophobic trifocal IOL and Descemet membrane endothelial keratoplasty in both eyes was performed at an interval of 2 months between the eyes. At 12 months, the uncorrected distance visual acuity was 20/16 in each eye, with uncorrected near visual acuity of 20/20 for 40 to 60 cm from the face. The endothelial cell count at 12 months was 2250 cells/mm and 2120 cells/mm in right and left eyes, respectively.
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http://dx.doi.org/10.1097/j.jcrs.0000000000000104DOI Listing
March 2020

Misdiagnosed opacification of a hydrophobic acrylic intraocular lens.

J Cataract Refract Surg 2019 10;45(10):1512-1514

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom; Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, United Kingdom. Electronic address:

A 75-year-old woman was referred for decreased visual acuity resulting from "opacification of the IOL" in the immediate period after uneventful bilateral cataract surgery with single-piece AcrySof IQ intraocular lens (IOL) implantation. A neodymium:YAG laser capsulotomy had been performed in both eyes to treat the complication. Anterior segment optical coherence tomography performed at presentation showed an opaque membrane enveloping the IOL. The membrane was peeled from the anterior IOL surface, and all adherences between the IOL and capsular bag were freed. One year later, the eyes remained stable; the uncorrected distance visual acuity was 20/20, the IOL was clear, and there was no evidence of recurrence of the membrane. Appropriate imaging for the diagnosis and surgical peeling with freeing of the adhesions between the IOL and the capsular bag were essential to the success in this case.
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http://dx.doi.org/10.1016/j.jcrs.2019.07.024DOI Listing
October 2019

Epithelial ingrowth following LASIK managed with Nd:YAG laser.

Indian J Ophthalmol 2019 09;67(9):1474

Sussex Eye Hospital, Brighton, United Kingdom.

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http://dx.doi.org/10.4103/ijo.IJO_1825_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6727717PMC
September 2019

Changes in symmetry of anterior chamber following routine cataract surgery in non-glaucomatous eyes.

Eye Vis (Lond) 2019 3;6:19. Epub 2019 Jul 3.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF UK.

Background: To assess minimum and maximum changes in anterior chamber dimensions following routine cataract surgery in non-glaucomatous eyes.

Methods: Forty-two eyes (42 participants) underwent routine cataract surgery with same surgeon and were assessed preoperatively, 1, 3, 6 and 12 months postoperatively. Primary outcome measure: Angle-to-angle diameter (AAD) (at 0-180, 45-225, 90-270, 135-315), Anterior-chamber-angle (ACA) (at 0, 45, 90, 135, 180, 225, 270 and 315) and central anterior chamber depth (ACD) at all visits. Secondary outcome measures: relationship to axial length (AL).

Results: The mean AAD and ACA increased post-operatively in all meridians at all visits postoperatively. At 12 months, there was a maximum change in AAD in horizontal meridian (506.55 ± 468.71 μm) and least in vertical meridian (256.31 ± 1082.3 μm). The mean percentage increase in ACA postoperatively was least at 90 (5% increase compared to 29-35% elsewhere). Central ACD deepened at all postoperative visits and this did not change over 12 months. There was no correlation between AAD, ACA and ACD with AL at any visit.

Conclusion: The AAD, ACA and ACD increases following cataract surgery in non-glaucomatous eyes, but at 12 months increase in AAD is least in vertical compared to horizontal meridian. Also, ACA was narrower (only 5% increase) superiorly compared to elsewhere (29-35% increase in ACA). This may have implications with regards to surgeries performed in the anterior chamber and corneal endothelial cell loss.
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http://dx.doi.org/10.1186/s40662-019-0144-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6607582PMC
July 2019

Residual Refractive Astigmatism following Toric Intraocular Lens Implantation without Consideration of Posterior Corneal Astigmatism during Cataract Surgery with Low Anterior Keratometric Astigmatism upto 2.5 Dioptres.

Curr Eye Res 2019 12 5;44(12):1399-1406. Epub 2019 Jul 5.

Brighton & Sussex Medical School, University of Sussex, Brighton, UK.

: To determine the refractive astigmatism following toric intraocular lens (tIOL) implantation without consideration of posterior keratometric astigmatism with a conventional tIOL calculator for eyes with low keratometric astigmatism (0.75D to 2.5D) and to theoretically compare the outcomes with predicted refractive astigmatism using a calculator with Barrett's formula.: 34 eyes (34 patients) were assessed with Scheimpflug imaging and underwent tIOL implantation employing conventional tIOL calculator. Eyes were grouped on preoperative keratometric astigmatism as against-the-rule (ATR), with-the-rule (WTR), and oblique (OB). The refractive astigmatism was assessed at 1, 3, 6 and 12 months postoperatively and was classified as ATR, WTR, and OB. Theoretical refractive astigmatism calculations were performed for the same eyes using Barrett's formula.: Preoperatively keratometric astigamtism was ATR, WTR, and OB in 32%, 53% and 15% of eyes. At 12 months, in ATR, WTR and OB groups, 45.5%, 16.7% and 60% had ATR refractive astigmatism; 16.7%, 0%, and 20% had WTR refractive astigmatism; 55.6%, 54.5% and 20% were emmetropic (no sphere and cylinder) respectively. There was a significant difference between the theoretical predicted postoperative refractive astigmatism using conventional tIOL calculator and Barrett's formula ( < .05). Postoperative refractive astigmatism was not significantly different from the theoretical predicted refractive astigmatism with Barrett's formula but it was significantly higher than that with a conventional tIOL calculator.: At 12 months, with a conventional tIOL calculator, postoperative emmetropia is achieved in half, two third and one-fifth of eyes with preoperatively ATR, WTR, and OB keratometric astigamtism respectively. Around 1/4 WTR keratometric astigamtism eyes preoperatively were overcorrected to ATR refractive astigmatism whereas ½ATR remained undercorrected at 12 months Outcomes achieved were dissimilar to predicted outcomes with a conventional tIOL calculator but similar to those with Barrett's formula.
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http://dx.doi.org/10.1080/02713683.2019.1638418DOI Listing
December 2019

Impact of classifying keratoconus location based on keratometry or pachymetry on progression parameters.

Clin Exp Optom 2020 05 11;103(3):312-319. Epub 2019 Jun 11.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.

Background: This study sought to assess the impact of classifying keratoconus location based on thinnest pachymetry or maximum keratometry (Kmax) on progression parameters after corneal crosslinking (CXL).

Methods: In this observational study, patients were followed up at one, three, six and 12 months after CXL. All patients underwent visual acuity, Scheimpflug tomography and slitlamp assessment at all follow-ups. Keratoconus was classified as central, paracentral and peripheral based on X and Y co-ordinates of either thinnest pachymetry (Group 1) or Kmax (Group 2). Progression parameters Kmax, ABCD grading, anterior, posterior and total wavefront (WF) aberrations were compared between the groups.

Results: Fifty-two eyes (43 patients) were classified into Groups 1 and 2: there were 82.8 per cent, 13.4 per cent, 3.8 per cent and 42.3 per cent, 38.4 per cent, 19.2 per cent central, paracentral and peripheral cones respectively. Central cones: Group 1: 'C' decreased after three months, Kmax, 'A', anterior and total WF decreased after six months. Group 2: Kmax, anterior and total WF decreased after three months, 'A' decreased at 12 months, whereas 'C' increased from three months. Paracentral cones: Group 1: no significant changes. Group 2: Kmax and 'A' decreased after six months, 'C' increased after three months. Peripheral cones: Group 1: no significant changes. Group 2: 'C' increased only at one month.

Conclusion: Thinnest pachymetry and Kmax should not be used interchangeably when categorising keratoconus. Although keratoconus may have thin cornea centrally, the Kmax may not be central. For the majority of parameters considered for monitoring progression, changes were noticed earlier when the keratoconus was classified based on Kmax.
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http://dx.doi.org/10.1111/cxo.12927DOI Listing
May 2020

Edge profile of commercially available square-edged intraocular lenses: Part 2.

J Cataract Refract Surg 2019 06 28;45(6):847-853. Epub 2019 Mar 28.

Image and Analysis Unit, University of Brighton, England.

Purpose: To analyze the sharpness of the posterior optic edge and edge thickness of intraocular lenses (IOLs) marketed with a square-edged profile.

Setting: University of Brighton and Brighton and Sussex University Hospitals NHS Trust, Brighton, England.

Design: Laboratory study.

Methods: Fourteen square-edged 20.0 diopter IOLs were analyzed, including 9 hydrophobic IOLs (AF-1, AF-1 iSert, Clareon, EyeCee One Crystal, CT Lucia, Envista, EyeCee One, Vivinex iSert, and RayOne Hydrophobic) and 5 hydrophilic IOLs (Asphira, CT Asphina, Incise, Synthesis, and RayOne Hydrophilic). All the IOLs were scanned following a previously published standardized technique using environmental scanning electron microscopy. The posterior optic edges were scanned at a magnification of ×500 and ×200 to measure the radius of curvature of the posterior optic edges and the optic edge thickness.

Results: The radius of curvature of the posterior optic edges ranged from 4.6 to 20.6 μm. Except for the Incise IOL (7.7 μm), all hydrophilic IOLs (Synthesis [10.6 μm], Asphira [13.7 μm], RayOne Hydrophilic [14.0 μm], CT Asphina [13.7 μm]) had a radius of curvature greater than 10.0 μm. For the hydrophobic IOLs, the radius of curvature was less than 10.0 μm for the Clareon (7.9 μm), EyeCee One Crystal (4.7 μm), Vivinex iSert (7.6 μm), and CT Lucia (4.6 μm), and greater than 10.0 μm for the Envista (19.7 μm), EyeCee One (13.7 μm), AF-1 iSert (19.7 μm), AF-1 (19.7 μm) and the RayOne Hydrophobic (20.6 μm). The Vivinex iSert (150.5 μm) and the Incise (218.2 μm) were the thinnest IOLs, and the RayOne Hydrophobic (375.8 μm) and RayOne Hydrophilic IOLs (477.1 μm) were the thickest of the hydrophobic and hydrophilic IOLs, respectively.

Conclusions: Commercially marketed square-edged IOLs still differed in the sharpness of the posterior optic edge. More hydrophobic IOLs have rounder edges than those studied 10 years ago. Variations in the edge profile of hydrophobic IOLs were greater compared with the hydrophilic IOLs.
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http://dx.doi.org/10.1016/j.jcrs.2018.12.004DOI Listing
June 2019

Influence of peripheral corneal relaxing incisions during cataract surgery for corneal astigmatism up to 2.5 dioptres on corneal densitometry.

Eye (Lond) 2019 05 2;33(5):804-811. Epub 2019 Jan 2.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Eastern Road, Brighton, BN2 5BF, UK.

Purpose: To assess the effect of peripheral corneal relaxing incisions (PCRI) for astigmatism between 0.75 and 2.5 dioptres during cataract surgery on corneal densitometry (CD).

Methods: In this prospective, randomised study, 80 eyes (80 patients), received either tIOL or PCRI. Assessment at pre-operative and 1, 3, 6, 12 months post-operative visit included uncorrected (UCDVA) and best-corrected distance visual acuity (BCDVA), spherical equivalent (SEQ) (only post-operatively), mean anterior and posterior keratometric astigmatism (K) and CD with Schiempflug system. CD was analysed in four concentric radial zones from centre to periphery (Zone 1 to 4) and in 3 layers (anterior, mid-stromal and posterior).

Results: Comparing tIOLs vs. PCRIs, there was no significant difference in the UCDVA, BCDVA and SEQ. In PCRI group, anterior K decreased at 1 month and remained stable thereafter. For zones 1, 2 and 3, CD significantly reduced after 3 months with tIOLs whereas with PCRIs, it reduced 1 month onwards. For zone 4, CD reduced only at 12 months with tIOLs compared to 3 months onwards with PCRIs. In both groups CD was higher in the zone 4 and anterior layer. Significant reduction in CD was found in all three layers of cornea after 3 months in tIOL and after first month in PCRI groups, respectively.

Conclusions: Cataract surgery alone reduces the CD. Reducing keratometric astigmatism with PCRIs shows significant differences in CD from early post-operative period for central and anterior corneal layer.
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http://dx.doi.org/10.1038/s41433-018-0327-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6707177PMC
May 2019
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