OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY MORPHOLOGY AFTER RHEGMATOGENOUS RETINAL DETACHMENT REPAIR: ALIGN Post Hoc Analysis.

PURPOSE: To compare foveal avascular zone (FAZ) geometric indices using optical coherence tomography angiography (OCTA) in pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD). FAZ morphology was assessed as a possible imaging feature of retinal displacement. METHODS: This ALIGN post hoc analysis included primary fovea-off RRDs that underwent successful PnR or PPV, and performed OCTA, and fundus autofluorescence at (FAF) 3 months postoperatively at St. Michael's Hospital, Toronto, Canada. FAZ area (mm 2 ), axial ratio, circularity, and roundness were measured, and FAF images were assessed for retinal displacement. RESULTS: Seventy-two patients were included, 78% (56/72) were male mean age was 60 ± 9 years, and 60% (43/72) were phakic. Sixty-five percent (47/72) and 35% (25/72) underwent PnR and PPV, respectively. The mean baseline logarithm of the minimum angle of resolution visual acuity was 1.49 ± 0.76. FAZ circularity was lower after PPV (0.629 ± 0.120) versus PnR (0.703 ± 0.122); P = 0.016. Sixty-six patients had gradable FAF images. Retinal displacement was present in 29% (19/66), 84.2% (16/19) of which had displacement in the macula. FAZ circularity was lower in eyes with displacement in the macula (0.613 ± 0.110) versus those without displacement (0.700 ± 0.124); P = 0.015. There was a moderate negative correlation between 12-month aniseikonia and FAZ circularity(r = -0.262; P = 0.041). CONCLUSION: FAZ circularity was lower after PPV and in eyes with retinal displacement in the macula. Circularity was negatively correlated with 12-month aniseikonia scores. FAZ circularity may be another imaging feature to consider postoperatively after RRD repair.

Imaging Biomarkers and Their Impact on Therapeutic Decision-Making in the Management of Neovascular Age-Related Macular Degeneration.

These recommendations, produced by a group of Canadian retina experts, have been developed to assist both retina specialists and general ophthalmologists in the management of vision-threatening neovascular age-related macular degeneration (nAMD). The recommendations are based on published evidence as well as collective experience and expertise in routine clinical practice. We provide an update on practice principles for optimal patient care, focusing on identified imaging biomarkers, in particular retinal fluid, as well as current and emerging therapeutic approaches. Algorithms for delivering high-quality care and improving long-term patient outcomes are provided, with an emphasis on timely and appropriate treatment to preserve and maintain vision. In the context of nAMD, increasing macular fluid or leakage on fluorescein angiography (FA) may indicate disease activity regardless of its location. Early elimination of intraretinal fluid (IRF) is of particular relevance as it is a prognostic indicator of worse visual outcomes. Robust referral pathways for second opinion and peer-to-peer consultations must be in place for cases not responding to intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy.

The Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).

PURPOSE: The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for the management of primary RRD. DESIGN: Prospective, randomized controlled trial. PARTICIPANTS: Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina. METHODS: Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively. MAIN OUTCOME MEASURES: The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success. RESULTS: One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001). CONCLUSIONS: Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfilling Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.

Multidisciplinary amyotrophic lateral sclerosis telemedicine care: The store and forward method.

INTRODUCTION: Amyotrophic lateral sclerosis (ALS) patients benefit from multidisciplinary care in an ALS clinic. We studied whether multidisciplinary care of ALS patients using the store and forward method of telemedicine was feasible and acceptable to patients and providers. METHODS: ALS patients seen in the University of Florida (UF) Jacksonville ALS clinic were eligible for our study. A trained telemedicine nurse performed and recorded a multidisciplinary assessment of the patient in their home. Clinic team members reviewed the assessments and provided recommendations, and the clinic director discussed the plan with the patient via videoconference. Patient and provider satisfaction was evaluated using surveys. RESULTS: Eighteen patients completed a total of 27 telemedicine visits. Patient satisfaction was excellent and provider satisfaction was very good. DISCUSSION: The store and forward method of telemedicine is an acceptable alternative to live telemedicine for the multidisciplinary care of ALS patients. This method of care may improve access to multidisciplinary care for this patient population. Muscle Nerve 59:34-39, 2019.

Same-Day Bilateral Intravitreal Anti-Vascular Endothelial Growth Factor Injections: Experience of a Large Canadian Retina Center.

OBJECTIVE: To evaluate the outcomes and complications of bilateral same-day intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections. METHODS: This is a single-center, retrospective study that included 524 eyes of 262 patients who received concomitant bilateral intravitreal anti-VEGF injections in 2016 at St. Michael's Hospital, Toronto. If any of the patients were receiving simultaneous bilateral injections on a regular basis prior to 2016, data pertaining to previous injections were also reviewed. Everyone received bevacizumab, ranibizumab, or aflibercept in an office setting. RESULTS: A total of 9,798 intravitreal anti-VEGF injections (4,899 bilateral injection sessions) were performed in 524 eyes of 262 patients. The average number of bilateral injection sessions per patient was 18.7 ± 14.1. Ranibizumab was the most commonly used anti-VEGF drug (83.8%). The incidence of endophthalmitis was 0.01%, and there were 2 episodes of acute intraocular inflammation among the 9,798 injections (0.02%). All 3 cases occurred after treatment with ranibizumab. There were 2 deaths (0.76%) due to nonvascular causes but no vascular related systemic adverse events were reported. CONCLUSIONS: Same-day bilateral intravitreal anti-VEGF injections present a low rate of complications and are well tolerated by patients. This safe practice may reduce the burden on the health-care system and on the patients.

PROPORTION OF PATIENTS WITH MACULAR HOLE SURGERY WHO WOULD HAVE BEEN FAVORABLE OCRIPLASMIN CANDIDATES: A Retrospective Analysis.

PURPOSE: To identify favorable ocriplasmin candidates from a cohort of idiopathic full thickness macular hole surgery patients. METHODS: The records of patients with full thickness macular hole who underwent pars plana vitrectomy surgery between 2011 and 2015 were reviewed. Clinical data collected included patient demographics, pre- and post-operative Snellen visual acuity, optical coherence tomography findings, and lens status. The authors defined "favorable" ocriplasmin candidates as patients with focal vitreomacular traction, no epiretinal membrane, and hole size ≤400 µm. The authors further categorized "optimal" candidates as age ≤65, phakic, no epiretinal membrane, with focal vitreomacular traction, and hole size ≤400 µm. RESULTS: The records of 238 patients were assessed; 30.7% were male while mean age was 68.6 ± 8.3 years. The mean logMAR acuity was 1.2 (Snellen 20/317) preoperatively and 0.90 (Snellen 20/159) postoperatively. Optical coherence tomography findings indicated that 46.5% of the macular holes studied were less than ≤400 µm in size, 14.8% had an epiretinal membrane, and 25.3% had vitreomacular traction. A total of 17.7% of study patients were found to be favorable candidates, whereas 3.8% were optimal ocriplasmin candidates. CONCLUSION: Only a minority of full thickness macular hole surgical candidates in this cohort would be considered favorable ocriplasmin candidates.

AQUEOUS HUMOR CYTOKINE LEVELS AS BIOMARKERS OF DISEASE SEVERITY IN DIABETIC MACULAR EDEMA.

PURPOSE: To determine whether aqueous cytokine levels correlate with disease severity in diabetic macular edema. METHODS: A prospective cross-sectional study of 49 adults with diabetes mellitus, centre-involving diabetic macular edema and central subfield macular thickness ≥310 µm on spectral domain optical coherence tomography. Clinical examination and aqueous sampling were carried out before an initial injection of ranibizumab. Multiplex immunoassay of sample was carried out for vascular endothelial growth factor, placental growth factor, transforming growth factor beta, intercellular adhesion molecule-1, interleukin (IL)-2, IL-3, IL-6, IL-8, IL-10, IL-17, vascular cell adhesion molecule-1, monocyte chemoattractant protein-1, and epidermal growth factor. Multivariate robust regression models were constructed, and adjusted for age, lens status, or severity of retinopathy, and size of foveal avascular zone. RESULTS: Spectral domain optical coherence tomography macular volume was an excellent measure of disease severity, correlating strongly with central subfield macular thickness (P < 0.001), best-corrected Snellen visual acuity (P < 0.001), and baseline diabetic retinopathy severity (P = 0.01). Elevated aqueous intercellular adhesion molecule-1 correlated with greater macular volume (P = 0.002). No aqueous cytokine, including VEGF, correlated with central subfield macular thickness. There was an association between IL-10 levels and best-corrected Snellen visual acuity (P = 0.03). CONCLUSION: Aqueous intercellular adhesion molecule-1 correlates with disease severity as measured by macular volume on spectral domain optical coherence tomography, and IL-10 is associated with BCVA. Intercellular adhesion molecule-1 may be a clinically useful biomarker for diabetic macular edema severity.

Identifying Predictors of Anti-VEGF Treatment Response in Patients with Neovascular Age-Related Macular Degeneration through Discriminant and Principal Component Analysis.

OBJECTIVE: AURA was an observational study that monitored visual acuity outcomes following ranibizumab use in neovascular age-related macular degeneration patients over 2 years. The aim of this analysis was to identify factors that were predictive of visual acuity outcomes in AURA. METHODS: The correlation between the baseline characteristics, the use of resources and the visual acuity outcomes in AURA was explored using principal component analysis (PCA) and partial least-squares-discriminant analysis (PLS-DA). The response variables analysed were mean change in visual acuity over 2 years (analysed via PCA) and no decline in visual acuity at 2 years compared with baseline (analysed via PLS-DA). RESULTS: The AURA dataset comprised 2,227 patients and 132 variables. Using PCA and PLS-DA, we found that the number of ranibizumab injections, clinic and monitoring visits, number of optical coherence tomography scans and ophthalmoscopies correlated with a change in visual acuity at Years 1 and 2, and are therefore key drivers of treatment success. CONCLUSION: This is a novel approach to graphically explore relationships between multiple correlated covariates and outcomes in real-life ophthalmology studies. It identified a number of variables that are positively linked with treatment outcomes.

Optimal Treatment of Retinal Vein Occlusion: Canadian Expert Consensus.

BACKGROUND: The availability of new therapeutic approaches, particularly intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapies, has prompted significant changes to the established treatment paradigms for retinal vein occlusion (RVO). Better visual outcomes and significantly lower rates of adverse events have been noted in multiple large randomized clinical trials and have led to a new standard of care for this sight-threatening condition. OBJECTIVE: To develop an expert consensus for the management of RVO and associated complications in the context of recent clinical evidence. METHODS: The development of a Canadian expert consensus for optimal treatment began with a review of clinical evidence, daily practice, and existing treatment guidelines and algorithms. The expert clinicians (11 Canadian retina specialists) met on February 1, 2014, in Toronto to discuss their findings and to propose strategies for consensus. RESULTS: The result of this expert panel is a consensus proposal for Canadian ophthalmologists and retina specialists treating patients presenting with RVO. Treatment algorithms specific to branch and central RVO (BRVO and CRVO) were also developed. CONCLUSIONS: The consensus provides guidelines to aid clinicians in managing RVO and associated complications in their daily practice. In summary, laser remains the therapy of choice when neovascularization secondary to RVO is detected. Adjunctive anti-VEGF could be considered in managing neovascularization secondary to RVO in cases of vitreous hemorrhage. Intravitreal anti-VEGF should be considered for symptomatic visual loss associated with center-involving macular edema on optical coherence tomography. Patients with BRVO and a suboptimal response to anti-VEGF could be treated with grid laser, and those with CRVO and an inadequate response to anti-VEGF may be candidates for intravitreal steroids.

Two-year outcomes of different subretinal fluid drainage techniques during vitrectomy for fovea-off rhegmatogenous retinal detachments: ELLIPSOID-2 study.

BACKGROUND: The purpose of the study is to compare visual acuity, complications and outer retinal integrity following subretinal fluid (SRF) drainage from the peripheral retinal breaks (PRBs) versus posterior retinotomy (PR) versus perfluorocarbon liquid (PFCL) for macula-off rhegmatogenous retinal detachments (RRDs) at 2 years post-surgery. METHODS: Retrospective analysis of 300 consecutive patients with primary RRD undergoing 23-gauge pars plana vitrectomy with SRF drainage through (1) PRB (n=100), (2) PR (n=100) or (3) with PFCL (n=100). Primary outcomes were visual acuity (best-corrected visual acuity (BCVA)) and complications (cystoid macular oedema (CMO) and epiretinal membrane (ERM)). Secondary outcomes were discontinuity of the external limiting membrane (ELM), ellipsoid zone (EZ) and interdigitation zone (IDZ) at 2 years post-surgery. RESULTS: Mean (±SD) logMAR BCVA at 24 months was better in the PRB compared with PR and PFCL, with PFCL having the worst BCVA (PRB 0.5±0.6; PR 0.7±0.5; PFCL 0.9±0.7, p=0.001). CMO was higher with PFCL (PRB 29.7%; PR 30.2%; PFCL 45.9%, p=0.0015) and ERM formation was higher in PR (PRB 62.6%; PR 93.0%; PFCL 68.9%, p=0.002). There were no differences in ELM or EZ discontinuity. However, IDZ discontinuity was higher in PFCL (PRB 34%; PR 27%; PFCL 46%, p=0.002) at 2 years. CONCLUSIONS: Visual acuity was worse and discontinuity of the IDZ and CMO was greater in eyes with PFCL-assisted drainage compared with PRB or PR. Drainage technique may impact long-term visual acuity and photoreceptor integrity.

Long-Term Re-Detachment Rates of Pneumatic Retinopexy versus Pars Plana Vitrectomy in Retinal Detachment: a PIVOT Post-Hoc Analysis.

PURPOSE: To assess long-term re-detachment rates of the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT). DESIGN: Randomized controlled trial. SUBJECTS: PIVOT trial participants METHODS: This study was performed at St. Michael's Hospital, Unity Health Toronto, Toronto, Canada. PIVOT trial participants, with a minimum follow-up of two years, who had undergone either pneumatic retinopexy or ppv for rrd repair were assessed for long-term re-detachment by chart review or telephone interview. The latter was the only accepted method for those with less than two years of follow-up. Patients were only eligible if no re-intervention to reattach the retina was performed within the first year of the initial procedure. MAIN OUTCOME MEASURES: Long-term re-detachment rates for pneumatic retinopexy versus ppv following RRD repair. RESULTS: 61 ppv participants and 62 pneumatic retinopexy participants were analyzed. The long-term re-detachment rate was 0% and 1.61% (1/62) in the ppv and pneumatic retinopexy groups, respectively (p= 0.32). The mean follow-up duration in years was 5.43+/-3.60 versus 5.51+/-3.03 in the ppv and pnr groups, respectively. CONCLUSION: There was no statistically significant difference in long-term re-detachment rates for pneumatic retinopexy vs ppv. Both procedures are durable treatment options for rrd over an extended period, rarely requiring additional intervention for re-detachment.

En Face OCT in Diagnosis of Persistent Subretinal Fluid and Outer Retinal Folds after Rhegmatogenous Retinal Detachment Repair.

PURPOSE: To evaluate the role of en face OCT as a diagnostic tool for the detection of persistent subretinal fluid (PSRF) and outer retinal folds (ORFs) after successful rhegmatogenous retinal detachment (RRD) repair. DESIGN: Observational post hoc analysis of 2 prospective surgical trials. PARTICIPANTS: All patients with gradable (signal strength ≥ 5 and no segmentation error) 6 × 6-mm2 macular cube scans obtained using spectral-domain OCT (Carl Zeiss Meditec) between 1 and 2 months after surgery were included in this study. METHODS: The scans were assessed for the presence or absence of PSRF or ORFs using en face OCT and cross-sectional B scans by 2 masked graders, with any disagreements adjudicated by a third senior masked grader. MAIN OUTCOME MEASURES: The sensitivity, specificity, and predictive accuracy (using area under the curve [AUC]) of en face OCT were compared with those of cross-sectional OCT, which is considered the gold standard. RESULTS: Two hundred twenty-three patients were included in this study. The Cohen kappa between the graders in the diagnosis of PSRF and ORFs using en face OCT was 0.84 and 0.86, respectively. The sensitivity of en face OCT was 100% (95% confidence interval [CI], 100%-100%) in the diagnosis of PSRF and 98.8% (95% CI, 96.5%-101.1%) in the diagnosis of ORFs. Similarly, the specificity of en face OCT was 98.7% (95% CI, 96.8%-100.5%) and 84.2% (95% CI, 78.1%-90.2%) in the diagnosis of PSRF and ORFs, respectively. The AUC was 0.99 for PSRF and 0.91 for ORFs. CONCLUSIONS: En face OCT has good sensitivity, specificity, and predictive accuracy (using AUC) in the diagnosis of PSRF and ORFs. En face OCT is an efficient screening tool for postoperative anatomic abnormalities, such as PSRF and ORFs, after RRD repair. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Persistent subfoveal fluid in pneumatic retinopexy versus pars plana vitrectomy for rhegmatogenous retinal detachment: posthoc analysis of the PIVOT randomised trial.

PURPOSE: To assess the incidence of persistent subfoveal fluid (PSFF) in pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) following rhegmatogenous retinal detachment (RRD) repair and to determine its association with functional outcomes. METHODS: Posthoc analysis of the PIVOT randomised trial. Eyes with gradable en face and cross-sectional spectral-domain optical coherence tomography (SD-OCT) scans at 1-2 months postoperatively were included. Primary outcome was the proportion of patients with PSFF following PnR versus PPV at 1-2 months postoperatively. Secondary outcomes included association of PSFF with Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at 3, 6 and 12 months and metamorphopsia score (MCHARTs) at 12 months. RESULTS: Of 176 participants enrolled in PIVOT, 158 (89.8%) had gradable SD-OCT scans. Intergrader agreement was 0.870 (Cohen's kappa). The incidence of PSFF was 16% (13/81) following PnR and 10.4% (8/77) following PPV (p=0.298; OR=1.65, 95% CI 0.64 to 4.23). Median ETDRS score at 3 months postoperatively between eyes with and without PSFF was 71 (IQR=58-78) and 78 (IQR=70-84), respectively (difference=7 letters, p=0.037), with no significant difference at subsequent 6-month and 12-month visits. Median metamorphopsia scores in patients with versus without PSFF were: horizontal: 0.1 (IQR=0-0.3) vs 0 (IQR=0-0.2) (difference=0.1, p=0.228) and vertical: 0.25 (IQR=0-0.4) vs 0 (IQR=0-0.2) (difference=0.25, p=0.148), respectively. CONCLUSIONS: There was no significant difference in the incidence of PSFF in eyes undergoing PnR versus PPV for RRD. The presence of PSFF at 1-2 months postoperatively was associated with worse ETDRS letter score at 3 months, but there was no difference at 1 year. TRIAL REGISTRATION NUMBER: NCT01639209.

Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study).

Purpose: To investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of center-involved diabetic macular edema (CI-DME). Methods: A single-blind prospective randomized controlled pilot trial was performed. In total, 30 eyes of 30 patients with CI-DME and best corrected visual acuity (BCVA) between, and including, 20/30 and 20/400 were enrolled. Enrolled eyes were randomized to 2 groups. Group 1 received intravitreal aflibercept injections (IVT-AFL) with sham laser. Group 2 received IVT-AFL with MP laser. Both groups were followed every 4 weeks for 48 weeks and retreatment was performed on pro re nata basis according to preset criteria. The main outcome measure was the average number of intravitreal injections for each group at 48 weeks. Secondary outcome measures included changes in BCVA and central macular thickness (CMT) at 24 and 48 weeks. Results: The average number of intravitreal injections at 48 weeks was similar between the groups (8.5±3.3 in Group 1 vs 7.9±3.6 in Group 2, p=0.61). After 48 weeks, both groups demonstrated an improvement in BCVA and CMT. However, the difference in improvement between the groups was not statistically significant (p=0.18 for BCVA and p=0.57 for CMT). Conclusion: Intravitreal injections of aflibercept led to improvements in BCVA and CMT at 24 and 48 weeks. Addition of MP laser to eyes in group 2 did not offer additional benefit in reducing treatment burden or improving CMT. Eyes that received MP laser showed a numerically greater improvement in BCVA, although this was not statistically significant. Clinicaltrialsgov Identifier: NCT03143192 March 8, 2017.

Outer Retinal Folds after Pars Plana Vitrectomy vs. Pneumatic Retinopexy for Retinal Detachment Repair: Post hoc analysis from PIVOT.

PURPOSE: To assess the incidence of postoperative outer retinal folds (ORFs) after pars plana vitrectomy (PPV) vs. pneumatic retinopexy (PnR) for rhegmatogenous retinal detachment (RRD) repair and to determine the association of ORFs with functional outcomes at 1 year. DESIGN: Randomized controlled trial. PARTICIPANTS: Patients with primary macula-off RRD meeting the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized (PIVOT) trial criteria who were randomly assigned to undergo PPV or PnR. METHODS: Post hoc analysis of the PIVOT trial. The incidence and quantitative morphologic features of ORFs were assessed using en face and cross-sectional OCT at 1 month postoperatively by 2 masked graders. The ETDRS letter score was measured and quantitative assessment of metamorphopsia was performed at 1 year. MAIN OUTCOME MEASURES: Proportion of patients with ORFs at 1 month postoperatively among those who underwent PPV versus PnR. The secondary outcomes included the association of ORFs with visual acuity (ETDRS letter score) and metamorphopsia via metamorphopsia charts at 12 months postoperatively. RESULTS: Of 176 participants enrolled in PIVOT, 88 were macula-off RRDs. Of them, 94.3% (83 of 88) underwent postoperative OCT scans that were gradable at month 1, 93.2% (41 of 44) in the PPV group and 95.5% (42 of 44) in the PnR group. The incidence of ORF formation was 34.1% (14 of 41) in the PPV group and 14.3% (6 of 42) in the PnR group (P = 0.034). The ETDRS letter score at 1 year was 65.7 ± 6.6 letters in patients with ORFs vs. 75.1 ± 1.4 letters in those without ORFs (difference = 9.4 letters, 95% confidence interval [CI] = 7.5-11.3, P = 0.047). Among patients in the PPV group alone, the mean ETDRS letter score at 1 year in patients with ORFs was 62.8 ± 24.7 letters, compared with 75.4 ± 9.2 letters in patients without ORF formation (difference = 12.6 letters, 95% CI = 0.05-24.59, P = 0.04). Horizontal and vertical metamorphopsia scores were similar in patients with and without ORFs: horizontal, 0.35 ± 0.12 vs. 0.29 ± 0.07 (difference = 0.06, 95% CI = 0.01-0.11, P = 0.69); vertical, 0.25 ± 0.07 vs. 0.29 ± 0.07 (difference = 0.04, 95% CI = 0-0.08, P = 0.60). There was a negative correlation between the closest distance of an ORF from the fovea and vertical metamorphopsia score (r = -0.507, P = 0.045). CONCLUSIONS: There is greater risk of developing ORFs after PPV compared to PnR for primary RRD. Outer retinal folds at 1 month are associated with significantly worse ETDRS visual acuity letter scores at 1 year.

Longitudinal Assessment of Ellipsoid Zone Recovery Using En Face Optical Coherence Tomography After Retinal Detachment Repair.

PURPOSE: Suboptimal functional outcomes after rhegmatogenous retinal detachment (RRD) repair may be related to photoreceptor abnormalities, including alterations of the ellipsoid zone (EZ) that may not be apparent on cross-sectional optical coherence tomography (OCT). This study assessed EZ recovery using en face OCT after RRD repair and its association with visual acuity. DESIGN: Post hoc analysis of a randomized controlled trial. METHODS: Patients with macula-off RRD were monitored at 3, 6, 12, and 24 months postoperatively and annually thereafter. En face OCT of the EZ slab were analyzed. Hyporeflective areas were colocalized with EZ abnormalities on cross-sectional OCT B-scans and measured by 2 masked graders. Primary outcome was change in area of EZ hyporeflectivity from 3 to 24 months, and its association with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity recovery was also assessed. RESULTS: In total, 271 images of 61 patients were assessed. Mean area of hyporeflectivity significantly decreased from 3 to 24 months (-2.98 mm2; 95% CI, 1.82-4.13 mm2; P < .0001), with further reductions up to 4 years. Linear regression revealed an association between change in hyporeflective area and change in the ETDRS letter score from 3 to 24 months (ß = -0.31, P = .009, R2 = 14.8%) and between duration of macula-off and change in hyporeflective area from 3 to 24 months (ß = -0.37, P = .018, R2 = 13.7%). CONCLUSIONS: En face OCT provides a novel biomarker for visualizing and quantifying EZ recovery after RRD repair that is associated with ETDRS visual acuity recovery. A steady decline in the area of EZ hyporeflectivity was observed over many years with delayed recovery in patients with longer duration of macula-off.

Glycemic Index Versus Wheat Fiber on Arterial Wall Damage in Diabetes: A Randomized Controlled Trial.

OBJECTIVE: High cereal fiber and low-glycemic index (GI) diets are associated with reduced cardiovascular disease (CVD) risk in cohort studies. Clinical trial evidence on event incidence is lacking. Therefore, to make trial outcomes more directly relevant to CVD, we compared the effect on carotid plaque development in diabetes of a low-GI diet versus a whole-grain wheat-fiber diet. RESEARCH DESIGN AND METHODS: The study randomized 169 men and women with well-controlled type 2 diabetes to counseling on a low GI-diet or whole-grain wheat-fiber diet for 3 years. Change in carotid vessel wall volume (VWV) (prespecified primary end point) was assessed by MRI as an indication of arterial damage. RESULTS: Of 169 randomized participants, 134 completed the study. No treatment differences were seen in VWV. However, on the whole-grain wheat-fiber diet, VWV increased significantly from baseline, 23 mm3 (95% CI 4, 41; P = 0.016), but not on the low-GI diet, 8 mm3 (95% CI -10, 26; P = 0.381). The low-GI diet resulted in preservation of renal function, as estimated glomerular filtration rate, compared with the reduction following the wheat-fiber diet. HbA1c was modestly reduced over the first 9 months in the intention-to-treat analysis and extended with greater compliance to 15 months in the per-protocol analysis. CONCLUSIONS: Since the low-GI diet was similar to the whole-grain wheat-fiber diet recommended for cardiovascular risk reduction, the low-GI diet may also be effective for CVD risk reduction.

Postoperative Photoreceptor Integrity Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Retinal Detachment Repair: A Post Hoc Optical Coherence Tomography Analysis From the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial.

IMPORTANCE: Pneumatic retinopexy (PnR) is associated with superior visual acuity and reduced vertical metamorphopsia compared with pars plana vitrectomy (PPV) for primary rhegmatogenous retinal detachment (RRD). It is important to determine postoperative photoreceptor integrity with both surgical techniques. OBJECTIVE: To compare photoreceptor integrity on spectral domain-optical coherence tomography (SD-OCT) between PnR and PPV at 12 months postoperatively. DESIGN, SETTING, AND PARTICIPANTS: Post hoc analysis of the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) conducted between August 2012 and May 2017 at St Michael's Hospital, Toronto, Ontario, Canada. Primary RRDs with specific criteria were included. Data were analyzed between April and August 2020. INTERVENTION: Randomization to PnR vs PPV stratified by macular status. MAIN OUTCOMES AND MEASURES: Difference in proportion of patients with discontinuity of the ellipsoid zone (EZ) and external limiting membrane (ELM) between groups assessed independently by 2 masked graders at an external masked image reading center. RESULTS: A total of 150 participants completed the 12-month follow-up visit. A total of 145 patients (72 PPV and 73 PnR) had gradable spectral-domain optical coherence tomography at 12 months. Analysis of the central 3-mm (foveal) scans found that 24% (n = 17 of 72) vs 7% (n = 5 of 73) displayed EZ discontinuity (difference, 17%; odds ratio [OR], 4.204; 95% CI, 1.458-12.116; P = .005) and 20% (n = 14 of 71) vs 6% (n = 4 of 73) displayed ELM discontinuity (difference, 14%; OR, 4.237; 95% CI, 1.321-13.587; P = .01) in the PPV and PnR groups, respectively. Analysis of the 6-mm (foveal and nonfoveal) scans revealed that EZ and ELM discontinuity was greater in the PPV vs PnR groups (EZ, 32% [n = 23 of 72] vs 11% [n = 8 of 73]; difference, 21%; OR, 3.814; 95% CI, 1.573-9.249; P = .002; ELM, 32% [n = 23 of 71] vs 18% [n = 13 of 73]; difference, 14%; OR, 2.211; 95% CI, 1.015-4.819; P = .04). CONCLUSIONS AND RELEVANCE: Discontinuity of the EZ and ELM was more common at 12 months postoperatively following PPV vs PnR for RRD repair. The findings of this post hoc analysis suggest that less discontinuity of the EZ and ELM may provide an anatomic basis for the previously reported superior functional outcomes with PnR, although the analysis does not prove a cause-and-effect relationship. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01639209.

Subconjunctival lidocaine before laser treatment: a randomized trial.

PURPOSE: The aim of the study was to determine whether subconjunctival anesthesia is effective at reducing pain associated with laser retinopexy. DESIGN: This was a single-center, prospective, patient-masked, randomized, controlled trial. PARTICIPANTS: In the primary study group, 65 patients were recruited. Thirty-two patients (32 eyes) received anesthetic injection, and 33 patients (33 eyes) received the sham injection. The crossover study group consisted of 28 patients (56 eyes). METHODS: Between February 2008 and April 2008, all patients who were consecutively booked to undergo panretinal photocoagulation (PRP) or peripheral laser retinopexy (PLR) were invited to participate in the study. Patients were randomized to receive subconjunctival lidocaine injection or a sham injection before their intended laser retinal treatment. These patients were defined as our primary study group. Patients who required a second laser treatment received the opposite injection in a masked fashion before laser retinal treatment. These patients were defined as our crossover group. Patients in both the primary study group and the crossover group were masked to the treatment given. After the laser treatment, patients completed a pain questionnaire. MAIN OUTCOME MEASURES: The primary outcome was incidence of pain. The secondary outcome was severity of pain. RESULTS: Primary study group: In the anesthetic treatment group, 19 patients (59%) experienced pain compared with 32 patients (97%) in the sham treatment group (P<0.001). Among the patients who did experience pain, the average pain score was 3.6 in the anesthetic treatment group and 4.1 in the sham treatment group (P=0.55). Crossover study group: In the anesthetic treatment group, 12 patients (43%) experienced pain compared with 28 patients (100%) in the sham treatment group (P<0.001). In patients who did experience pain, the average pain score was 3.3 in the anesthetic treatment group and 4.6 in the sham treatment group. Twenty patients (71%) preferred anesthetic to sham treatments, 1 patient (4%) preferred sham over anesthetic, and 7 patients (25%) thought both laser treatments were the same. CONCLUSIONS: Subconjunctival 2% lidocaine significantly reduces the incidence of pain in patients who receive PRP or PLR.