Design and Conduct of Randomized Clinical Trials Evaluating Surgical Innovations in Ophthalmology: A Systematic Review.

PURPOSE: Surgical innovations are necessary to improve patient care. After an initial exploratory phase, novel surgical technique should be compared with alternative options or standard care in randomized controlled trials (RCTs). However, surgical RCTs have unique methodological challenges. Our study sought to investigate key aspects of the design, conduct, and reporting of RCTs of novel surgeries. DESIGN: Systematic review. METHODS: The protocol was prospectively registered in PROSPERO (CRD42021253297). RCTs evaluating novel surgeries for cataract, vitreoretinal, glaucoma, and corneal diseases were included. Medline, EMBASE, Cochrane Library, and Clinicaltrials.gov were searched. The search period was January 1, 2016, to June 16, 2021. RESULTS: A total of 52 ophthalmic surgery RCTs were identified in the fields of glaucoma (n = 12), vitreoretinal surgery (n = 5), cataract (n = 19), and cornea (n = 16). A description defining the surgeon's experience or level of expertise was reported in 30 RCTs (57%) and was presented in both control and intervention groups in 11 (21%). Specification of the number of cases performed in the particular surgical innovation being assessed prior to the trial was reported in 10 RCTs (19%) and an evaluation of quality of the surgical intervention in 7 (13%). Prospective trial registration was recorded in 12 RCTs (23%) and retrospective registration in 13 (25%); and there was no registration record in the remaining 28 (53%) studies. CONCLUSIONS: Important aspects of the study design such as the surgical learning curve, surgeon's previous experience, quality assurance, and trial registration details were often missing in novel ophthalmic surgical procedures. The Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) framework aims to improve the quality of study design.

Long-term vision outcomes for patients with albinism and diabetic retinopathy.

PURPOSE: Albinism defines a group of genetic diseases which result from disordered melanin biosynthesis. Proliferative diabetic retinopathy (PDR) results from poorly controlled type 1 or 2 diabetes mellitus (DM) and can lead to blindness due to progressive neovascularisation. However, the treatment of PDR in patients with ocular/oculocutaneous albinism may be more challenging. In this study, we compared a group of patients with albinism and PDR, to a group with albinism and diabetes mellitus but no PDR, to examine the long-term implications. METHODS: Retrospective observational study included all patients with ocular albinism (OA) or oculocutaneous albinism (OCA) and DM who presented at a single specialist centre. Participants were allocated into either group 1 (eyes with PDR) or group 2 (all eyes without PDR). Statistical analysis was performed using SPSS V26.0. Between-group differences were investigated. RESULTS: Outcome data was available for 5 eyes from 3 participants in group 1 and 26 eyes from 13 participants in group 2. Despite interventions, a large and significant difference in vision at follow-up was observed between group 1 and group 2 (mean change in visual acuity: 1.11 (± 1.00) versus - 0.15 (± 0.46), respectively; p = < 0.0001). CONCLUSION: PDR is associated with poor long-term prognosis despite interventions for patients with albinism. Those without PDR appear to maintain stable vision. Alternative treatments for PDR and its complications may be required in this population. Measures to prevent the development of diabetic eye disease and progression towards PDR should be employed at an early stage.

Patient generated aerosol in the context of ophthalmic surgery.

OBJECTIVE: To assess the patterns of patient generated aerosol in the context of ophthalmic surgery and ophthalmic examinations. To inform medical teams regarding potential hazards and suggest mitigating measures. METHODS: Qualitatively, real-time time videography assessed exhalation patterns from simulated patients under different clinical scenarios using propylene glycol from an e-cigarette. Quantitatively, high-speed Schlieren imaging was performed to enable high resolution recordings analysable by MATLAB technical computing software. RESULTS: Without a face mask, the standard prior to COVID 19, vapour was observed exiting through the opening in the drape over the surgical field. The amount of vapour increased when a surgical mask was worn. With a taped face mask, the amount of vapour decreased and with inclusion of a continuous suction device, the least amount of vapour was seen. These results were equivocal when the patient was supine or sitting upright. High-speed Schlieren imaging corroborated these findings and in addition showed substantial increase in airflow egress during coughing and with ill-fitting face masks. CONCLUSION: Advising patients to wear a surgical mask at the time of ophthalmic interventions potentially contaminants the ocular field with patient generated aerosol risking endophthalmitis. Surgeon safety can be maintained with personal protective equipment to mitigate the increased egress of vapour from the surgical drape and taping, with or without suction is advisable, whilst meticulous hygiene around lenses is required at the time of slit lamp examination.

Foveal structure and visual function in nanophthalmos and posterior microphthalmos.

BACKGROUND/AIMS: The reason for visual impairment in patients with nanophthalmos and posterior microphthalmos is not completely understood. Therefore, this study aims to investigate foveal structure, and the impact of demographic, clinical and imaging parameters on best-corrected visual acuity (BCVA) in these conditions. METHODS: Sixty-two eyes of 33 patients with nanophthalmos (n=40) or posterior microphthalmos (n=22), and 114 eyes of healthy controls with high-resolution retinal imaging including spectral-domain or swept-source optical coherence tomography images were included in this cross-sectional case-control study. Foveal retinal layer thickness was determined by two independent readers. A mixed-effect model was used to perform structure-function correlations and predict the BCVA based on subject-specific variables. RESULTS: Most patients (28/33) had altered foveal structure associated with loss of foveal avascular zone and impaired BCVA. However, widening of outer nuclear layer, lengthening of photoreceptor outer segments, normal distribution of macular pigment and presence of Henle fibres were consistently found. Apart from the presence of choroidal effusion, which had significant impact on BCVA, the features age, refractive error, axial length and retinal layer thickness at the foveal centre explained 61.7% of the variability of BCVA. CONCLUSION: This study demonstrates that choroidal effusion, age, refractive error, axial length and retinal layer thickness are responsible for the majority of interindividual variability of BCVA as well as the morphological foveal heterogeneity in patients with nanophthalmos or posterior microphthalmos. This might give further insights into the physiology of foveal development and the process of emmetropisation, and support clinicians in the assessment of these disease entities.

Digital Transformation in Ophthalmic Clinical Care During the COVID-19 Pandemic.

ABSTRACT: COVID-19 has placed unprecedented pressure on health systems globally, whereas simultaneously stimulating unprecedented levels of transformation. Here, we review digital adoption that has taken place during the pandemic to drive improvements in ophthalmic clinical care, with a specific focus on out-of-hospital triage and services, clinical assessment, patient management, and use of electronic health records. We show that although there have been some successes, shortcomings in technology infrastructure prepandemic became only more apparent and consequential as COVID-19 progressed. Through our review, we emphasize the need for clinicians to better grasp and harness key technology trends such as telecommunications and artificial intelligence, so that they can effectively and safely shape clinical practice using these tools going forward.

OUTCOME OF REVISION PROCEDURES FOR FAILED PRIMARY MACULAR HOLE SURGERY.

PURPOSE: To analyze the outcomes of revision surgery for idiopathic full-thickness macular holes that have failed to close after primary surgery, and also to assess factors predicting success and to review the relative effect of adjunctive surgical techniques. METHODS: A multicenter retrospective study. Anatomical closure rates and visual acuity change between pre and postrevision surgery were assessed. Hole size, age, symptom duration, surgical interval, and reduced hole size were analyzed as predictive factors for success. Effectiveness of adjunctive surgical techniques was reviewed. RESULTS: Seventy-seven eyes were included in the study. Anatomical closure was achieved in 71% (55/77) cases. There was a median gain of 11 Early Treatment of Diabetic Retinopathy Score letters in all holes and 14 letters in closed holes. Full-thickness macular holes that increased in size by more than 10% following primary surgery had a closure rate of 50% compared with 80% in holes that reduced by 10% or stayed the same (P = 0.015). Increasing hole size is associated with a modest reduction in odds of closure (odds ratio = 0.99; P = 0.04). Surgical interval <2 months is not associated with better outcomes compared with >2 months (P = 0.14). CONCLUSION: Revision surgery for full-thickness macular holes that have failed to close after primary surgery is associated with high closure rates and significant visual gains.

The Association between Foveal Floor Measurements and Macular Hole Size.

PURPOSE: Determining which factors influence idiopathic macular hole (MH) size is important because it is a major prognostic indicator of treatment success. Foveal pit morphologic features are highly symmetrical within individuals and may influence idiopathic MH size. Using a series of patients with unilateral idiopathic MHs, we examined the foveal floor size of the fellow eye to evaluate its relationship with idiopathic MH size and postoperative outcomes. DESIGN: Retrospective observational study. PARTICIPANTS: Two hundred forty-one participants with a unilateral idiopathic MH treated with surgery and a fellow eye with no ocular pathologic features. METHODS: Both eyes underwent spectral-domain (SD) OCT imaging at the time of surgery. Minimum linear diameter (MLD) and base diameter (BD) defined idiopathic MH size. Foveal floor width (FFW) and minimal foveal thickness defined foveal pit morphologic features of the fellow eye. MAIN OUTCOME MEASURES: Baseline characteristics, SD OCT measurements, and preoperative variables were compared to determine their relationship with idiopathic MH size and postoperative visual acuity (VA) in logarithm of the minimum angle of resolution units. RESULTS: Foveal floor width was correlated with MLD (r = 0.36; P ≤ 0.001) and BD (r = 0.30; P ≤ 0.001), but not postoperative VA. Minimum linear diameter correlated with preoperative VA (r = 0.49; P ≤ 0.0001) and postoperative VA (r = 0.54; P ≤ 0.0001). A 2-stage regression model was developed to predict postoperative VA (r2 = 0.28): preoperative VA (ß = 0.36; P = 0.002) explained 13% of variability and MLD (ß = 0.29; P = 0.002), and idiopathic MH duration (ß = 0.23; P = 0.004) explained a further 16%. CONCLUSIONS: Foveal floor width of the fellow eye in patients with a unilateral idiopathic MH was correlated significantly with idiopathic MH size and may explain some of the variability in idiopathic MH size observed between individuals. However, FFW could not predict postoperative vision.

Determinants of vitreomacular traction width: associations with foveal floor width and vitreoretinal interface changes.

To investigate the relationship between vitreomacular traction (VMT) width, foveal floor width (FFW) and other anatomical characteristics between eyes of patients with VMT. Retrospective observational study of unilateral and bilateral VMT cases from two specialist ophthalmic centres in the United Kingdom (UK) between 2016 and 2018. For unilateral VMT cases: VMT width in the affected eye and FFW in the non-affected fellow eye were measured. In bilateral VMT cases: VMT width in both eyes was measured. In all cases, the presence of any associated inner or outer retinal, and vitreoretinal interface (VRI) changes, including epiretinal membrane, was also documented. 88 patients fulfilled the study criteria: 57 having unilateral and 31 bilateral VMT. For unilateral VMT cases, log (VMT) width was significantly correlated with FFW (r = 0.347, p = 0.008). Using stepwise linear regression, FFW (p = 0.004) and VRI changes (p = 0.03) were both significantly associated with VMT width with a R2 of 0.21. In bilateral VMT cases, there was strong positive correlation between log (VMT) width (r = 0.88, p < 0.001), and the presence of any VRI (r = 0.90, p < 0.001) or outer retinal changes (r = 0.50, p < 0.001) between the two eyes. These findings suggest that individual variations in foveal morphology as measured by the FFW, along with the presence of vitreoretinal interface changes, are associated with the extent of VMT width. VMT width, VRI and outer retinal changes were also highly correlated between eyes in bilateral VMT, suggesting that individual patient factors, which may be genetic or acquired, determine their presence and extent.

Contemporary Outcomes and Prognostic Factors of 23-Gauge Vitrectomy for Retained Lens Fragments After Phacoemulsification.

PURPOSE: To provide data on visual acuity (VA) outcomes and prognostic factors of microincision (23-gauge) vitrectomy surgery (MIVS) for retained lens fragments after complicated cataract surgery. DESIGN: Retrospective, interventional case series from 2012 to 2017. METHODS: Precataract surgery and intraoperative (vitrectomy) parameters, postvitrectomy complications, and best-corrected visual acuities (BCVAs) were identified. Vitrectomy was performed as early as corneal clarity permitted. Univariate and multivariate logistic regression were used to characterize factors associated with achieving VA better than 20/40, or worse than 20/200 at 6 months. RESULTS: This study included 291 consecutive eyes (291 patients). LogMAR BCVA improved from 0.73 ± 0.70 before cataract surgery to 0.46 ± 0.63 (P < .001) after vitrectomy. The previtrectomy VA was 1.43 ± 0.79. At 6 months, 183 (62.9%) and 45 patients (15.5%) achieved BCVAs better than 20/40 and worse than 20/200, respectively. Most frequent complications were de novo ocular hypertension (29 eyes, 10%) and transient cystoid macular edema (25 eyes, 8.6%). Postvitrectomy retinal detachment occurred in 9 eyes (3.1%). Final VA of 20/40 or better was independently associated only with better precataract surgery VA, age <75 years, absence of preexisting diabetic macular edema (DME) or postvitrectomy persistent cystoid macular edema (P < .05). Only poorer precataract surgery VA, delaying vitrectomy to later than 2 weeks, and final aphakic status were independently predictive of 20/200 or worse VA (P < .05). CONCLUSION: Contemporary VA outcomes of 23-gauge vitrectomy for retained lens fragments are comparable with that of prior predominantly non-MIVS cohorts, but fall short of benchmarks for uncomplicated cataract surgery. IOL type or timing of placement do not impact final VA.

Factors Associated with the Clinical Course of Vitreomacular Traction.

BACKGROUND: To analyze the optical coherence tomography (OCT) characteristics as well as the clinical and demographic features to investigate their possible role to the course of vitreomacular traction syndrome. METHODS: The inclusion criteria were vitreomacular adhesion with traction causing distortion of the retinal architecture, with or without the presence of an epiretinal membrane, regardless of the size of the adhesion; age >18 years; follow-up of at least three months; and adequate quality OCT scan. Measurements of foveal thickness, average macular thickness, macular volume, maximum vertical and horizontal vitreomacular adhesion, nasal and temporal angles of traction, hyaloid hyperreflectivity, the presence of an epiretinal membrane (ERM), and cone outer segment tips detachment were obtained. RESULTS: 150 eyes were included in the analysis. 36 eyes (24%) developed complete resolution at the last visit, 19 eyes (12.7%) formed a full-thickness macular hole, and 95 eyes (63.3%) showed no resolution of the traction. Better BCVA at the first visit was associated with an increased likelihood of resolution of the VMT, but increasing age, CMT, and BCVA in the end of the follow-up was associated with a reduction in the likelihood of resolving. Of the other variables that were studied, no statistical significant predictors were identified. CONCLUSIONS: Better BCVA in the first visit was associated with an increased likelihood of resolution of the VMT that occurred in 24% of our cases. Other factors such as the vertical area of adhesion and the angle of adhesion were not identified as prognostic factors affecting the clinical course of the disease.

WIDEFIELD SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING OF PERIPHERAL ROUND RETINAL HOLES WITH OR WITHOUT RETINAL DETACHMENT.

PURPOSE: To describe the widefield spectral-domain optical coherence tomography features of peripheral round retinal holes, with or without associated retinal detachment (RD). METHODS: Retrospective, observational study of 28 eyes with peripheral round retinal holes, with and without RD. Patients underwent imaging with a widefield 50-degree spectral-domain optical coherence tomography (Heidelberg Engineering, Germany) and Optos ultra-widefield imaging systems (Optos, United Kingdom). RESULTS: Vitreous attachment at the site of the retinal hole was detected in 27/28 (96.4%) cases. Cases were split into three groups: RHs with RD (n = 12); RHs with subretinal fluid (n = 5), and flat RHs (n = 11), with minimal or no subretinal fluid. 91.6% retinal holes associated with subretinal fluid or RD had vitreous attachment at the site of the hole. Eighty percent had vitreous attachment at both edges of the retinal hole, in a U-shape configuration, which appeared to exert traction. By contrast, flat retinal holes had visible vitreous attachment only at one edge of the retinal hole in 45.4%. CONCLUSION: Vitreous attachment was commonly seen at the site of round retinal holes. Vitreous attachment at both edges of the retinal hole in a U-shape configuration was more commonly seen at holes associated with subretinal fluid or RD.