Macular hole repair: the effect of size and nonsupine posture on postoperative outcomes.

Background: Postoperative face-down positioning (FDP) for up to 2 weeks is believed to be necessary for successful closure of macular holes. FDP, however, can be disabling and uncomfortable and is a major burden for elderly patients. The aim of this study was to investigate how nonsupine posturing and macular hole size affect anatomical and functional success of macular hole closure. Methods: The medical records of patients with idiopathic macular holes who were treated surgically between 2016 and 2019 were reviewed retrospectively. Exclusion criteria included vitreomacular traction, previous retinal detachment, or chronic macular hole. Results: A total of 115 eyes of 115 patients were included. Average age was 69.2 ± 8.2 years; 63 patients (55%) were female. Anatomical success was achieved in 108 patients (94%) with a single operation. In small holes (<400 µm), closure was seen in 98% of cases (95% CI, 94%-100%); in large holes (≥400 µm), 90% of cases (95% CI, 76%-94%). Visual acuity remained stable or improved in 108 patients (92%). Average preoperative best-corrected visual acuity was 1.02 ± 0.45, with an overall improvement of 5 lines postoperatively. Small holes and large holes improved, with an average of 3 versus 7 lines gained, respectively. Conclusions: In this study cohort, favorable anatomical and functional outcomes were achieved without postoperative FDP. These outcomes are comparable to the traditional FDP approach.

Internal limiting membrane flap with viscoelastic device for lamellar hole surgery with no postoperative positioning.

PURPOSE: To propose a novel technique of an internal limiting membrane (ILM) flap using ophthalmic viscoelastic device (OVD) with no requirement for postoperative head posture for the treatment of lamellar macular hole (LMH) repair. METHODS: A retrospective analysis of 16 consecutive eyes of LMH patients who underwent vitrectomy with ILM flap with OVD. Best-corrected visual acuity (BCVA), central macular thickness (CMT), simultaneous cataract extraction, and ellipsoid zone disruption preoperatively and at the final follow-up were compared. RESULTS: The mean age was 73.19 ± 7.26 years, and ten patients (62%) were females. The mean follow-up was 5.06±1.43 months (range 3-6). For all patients, BCVA was significantly improved at the final visit, from 0.65±0.36 logMAR units to 0.42±0.29 (p < 0.001). None of the patients had visual loss. Six patients had epiretinal membrane (ERM) foveoschisis, and the rest had LMH with epiretinal proliferation. Both subgroups presented a significant improvement in their BCVA with a trend for better improvement in the latter (p=0.09). Ellipsoid zone disruption was seen in 7 patients including one patient with a macular scar. There was no significant effect of ellipsoid zone disruption on the final BCVA (p=0.33). Twelve eyes (75%) underwent simultaneous cataract extraction. Mean BCVA at the final postoperative visit improved regardless of whether the eyes underwent simultaneous cataract surgery (p=0.39). CMT was also significantly improved at the final visit, from 200.06±46.8 µm preoperatively to 305.00±85.5 µm (p<0.001). No full-thickness macular holes were developed postoperatively. No intraoperative or postoperative complications were observed. CONCLUSIONS: Treatment of LMH with ILM flap with OVD showed promising anatomical and functional results with no postoperative head position requirements.

KESTREL and KITE: 52-Week Results From Two Phase III Pivotal Trials of Brolucizumab for Diabetic Macular Edema.

PURPOSE: To compare the efficacy and safety of brolucizumab with aflibercept in patients with diabetic macular edema (DME). DESIGN: Double-masked, 100-week, multicenter, active-controlled, randomized trials. METHODS: Subjects were randomized 1:1:1 to brolucizumab 3 mg/6 mg or aflibercept 2 mg in KESTREL (n = 566) or 1:1 to brolucizumab 6 mg or aflibercept 2 mg in KITE (n = 360). Brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by 12-week (q12w) dosing, with optional adjustment to every 8 weeks (q8w) if disease activity was identified at predefined assessment visits; aflibercept groups received 5 doses every 4 weeks (q4w) followed by fixed q8w dosing. The primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 52; secondary endpoints included the proportion of subjects maintained on q12w dosing, change in Diabetic Retinopathy Severity Scale score, and anatomical and safety outcomes. RESULTS: At Week 52, brolucizumab 6 mg was noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters vs +10.5 letters; KITE: +10.6 letters vs +9.4 letters; P < .001), more subjects achieved central subfield thickness (CSFT) <280 µm, and fewer had persisting subretinal and/or intraretinal fluid vs aflibercept, with more than half of brolucizumab 6 mg subjects maintained on q12w dosing after loading. In KITE, brolucizumab 6 mg showed superior improvements in change of CSFT from baseline over Week 40 to Week 52 vs aflibercept (P = .001). The incidence of ocular serious adverse events was 3.7% (brolucizumab 3 mg), 1.1% (brolucizumab 6 mg), and 2.1% (aflibercept) in KESTREL; and 2.2% (brolucizumab 6 mg) and 1.7% (aflibercept) in KITE. CONCLUSION: Brolucizumab 6 mg showed robust visual gains and anatomical improvements with an overall favorable benefit/risk profile in patients with DME.

Effectiveness and safety of ranibizumab in patients with central retinal vein occlusion: results from the real-world, global, LUMINOUS study.

OBJECTIVE: To evaluate the effectiveness, treatment patterns and long-term safety of ranibizumab 0.5 mg in treatment-naïve patients with central retinal vein occlusion (CRVO) in a real-world setting. METHODS: LUMINOUS, a 5-year, global, prospective, multicentre, multi-indication, observational, open-label study, recruited treatment naïve or prior treated patients who were treated as per the local ranibizumab label. Here, we report the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure over year (Y) 1 and 5-year safety in treatment-naïve CRVO patients. RESULTS: At baseline, the mean age of treatment-naïve CRVO patients (n = 327) was 68.9 years, with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) letters with 1, 2-3, 4-5, 6-8 and >8 ranibizumab injections, respectively. Mean (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 11.3%/8.6% and 1.2%/6.7%, respectively. CONCLUSIONS: These results demonstrate the effectiveness of ranibizumab in treatment-naïve CRVO patients at Y1 with clinically meaningful VA gains and no new safety findings over five years. These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes.

INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE WITHOUT POSTOPERATIVE FACE-DOWN POSITIONING FOR MACULAR HOLE REPAIR.

PURPOSE: To describe the outcomes of the inverted internal limiting membrane flap technique without postoperative face-down positioning for macular hole (MH) closure. METHODS: This retrospective longitudinal study identified patients who had undergone surgical repair for large (>400 µm), idiopathic MHs and did not maintain face-down positioning postoperatively. Outcome measures included anatomical success, defined as confirmation of hole closure by the optical coherence tomography scan and functional success and defined as improved best-corrected visual acuity from baseline at the last follow-up. RESULTS: Of the 63 eyes enrolled in the study, 94% patients (59 of 63) achieved anatomical success and 91% patients (57 of 63) achieved functional success. Fifteen (15) of these patients presented with a MH >600 µm. This subgroup achieved an anatomical success rate of 93% and a functional success rate of 87%. Statistically significant improvement in best-corrected visual acuity was demonstrated for all subgroups of MH size (P < 0.001). CONCLUSION: We report a high success rate of large, idiopathic MH closure with the inverted internal limiting membrane flap technique without postoperative face-down positioning. The results described in this study are favorable. However, larger studies with prospective design are warranted to explore this further.

Visual and anatomical outcomes associated with treat-and-extend administration of intravitreal aflibercept for neovascular age-related macular degeneration.

PURPOSE: To investigate the visual and anatomical outcomes associated with treat-and-extend (TAE) regimen of intravitreal (IVT) aflibercept in eyes with treatment naïve neovascular age-related macular degeneration (nvAMD). METHODS: A retrospective chart review of eyes that underwent IVT aflibercept injections for nvAMD between May 2014 and March 2018 was performed. The primary outcome was the change in best corrected visual acuity (BCVA) at 12 months. Secondary outcomes included the change in central retinal thickness (CRT), subretinal fluid (SRF) and intraretinal fluid (IRF). RESULTS: Data from 213 eyes of 213 patients (138 female, 65%) met the inclusion criteria. The mean (SD) age of the patients was 80.4 (± 9.2) years. The mean baseline BCVA (0.92 ± 0.50 logMAR, improved by 0.20 (± 0.40) logMAR units at 12 months (p < 0.001). Seventy-two (34%) eyes gained ≥ 0.3 logMAR and 47 (22%) eyes achieved BCVA ≤ 0.3 logMAR at 12 months. Baseline BCVA, patient age, and the number of aflibercept injections received were predictors of the change in BCVA at 12 months. Mean CRT improved from 347 (± 117) µm at baseline to 246 (± 55) µm at 12 months (p < 0.001). The percentage of eyes with SRF and IRF on SD-OCT declined from 63 to 21% and from 60 to 26% at 12 months, respectively. CONCLUSION: A TAE regimen of IVT aflibercept in treatment naïve nvAMD is associated with good visual and anatomical outcomes in routine clinical practice. Resolution of exudation occurred in about half of nvAMD cases at 12 months. Individualized administration of IVT aflibercept may reduce injection burden.

Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study.

PURPOSE: To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in prior ranibizumab-treated patients with neovascular age-related macular degeneration (nAMD) enrolled in the LUMINOUS™ study. PATIENTS AND METHODS: LUMINOUS, a 5-year, prospective, multicenter, observational study, recruited 30,138 adult patients (treatment-naïve or prior ranibizumab-treated or other ocular treatments) across all approved indications for ranibizumab. Patients were treated as per local ranibizumab label of participating countries. Here we report the mean change in visual acuity (VA) at Year 1, treatment exposure, overall incidence of ocular, non-ocular adverse events (AEs) and serious AEs (SAEs) in prior ranibizumab-treated nAMD patients (n = 16,167). RESULTS: At baseline, the mean (standard deviation [SD]) age of patients was 78.4 (9.0) years, 59.0% were female, and 80.0% were Caucasian. At Year 1 (n = 10,168), the mean (SD) VA change was -1.6 (12.6) letters (baseline VA: 58.3 [19.0] letters) with a mean (SD) of 4.7 (3.1) ranibizumab injections. Stratified by duration of prior ranibizumab treatment of <1 (n = 4,112), 1 to <2 (n = 2,095), 2 to <3 (n = 1,506), 3 to <4 (n = 1,123), 4 to <5 (n = 689), and ≥5 (n = 256) years, the mean (SD) VA change at Year 1 were -1.2 (13.5), -2.0 (12.3), -2.0 (11.3), -1.9 (11.8), -2.5 (10.9), and 0.0 (11.2) letters, respectively. Mean (SD) VA change in patients who received ≤6 and >6 injections over 1 year was -1.8 (13.8) and +0.5 (12.5) letters, respectively. The rate of ocular/non-ocular AEs and SAEs across all prior ranibizumab-treated patients over 5 years were 13.29%/23.02% and 0.84%/13.66%, respectively. CONCLUSIONS: Overall, regardless of the prior ranibizumab-treatment duration, VA was maintained in these patients at Year 1, and those receiving ≥6 injections showed a trend towards gaining letters. There were no new safety signals. These results may help inform routine clinical practice to appropriately treat nAMD patients with ranibizumab to achieve optimal visual outcomes.

Outcomes of Rhegmatogenous Retinal Detachment Repair With Nonrestricted Postoperative Positioning.

Purpose: To investigate the anatomical success rate associated with rhegmatogenous retinal detachment (RRD) repair without postoperative head positioning. Methods: Data on 182 individuals undergoing pars plana vitrectomy (PPV) with or without phacoemulsification or scleral buckle for primary RRD with intraocular tamponade were retrospectively reviewed. The primary outcome was the initial anatomical success rate. Secondary outcome measures were the change in best-corrected visual acuity and the final reattachment rate. Results: A total of 122 eyes from 122 patients who underwent RRD repair without postoperative positioning were included in this study. PPV alone was performed in 39% of cases, whereas the remaining patients had PPV combined with phacoemulsification (35%), with scleral buckle (19%), or both (7%). Inferior breaks between the 4 o'clock and 8 o'clock positions were present in 47% of cases. Primary and final anatomical success was achieved in 86% and 98% of cases, respectively. The most common cause for redetachment was proliferative vitreoretinopathy. Age and combined inferior retinal and superior breaks were predictive of recurrence in the logistic regression model. The mean baseline best-corrected visual acuity improved from 1.2 (Snellen equivalent, 20/320) to 0.76 (Snellen, 20/125) logarithm of the minimum angle of resolution after retinal reattachment (P < .001). Conclusions: PPV combined with or without phacoemulsification or scleral buckle for primary RRD in pseudophakic eyes or those rendered pseudophakic is associated with good anatomical outcomes without restricted postoperative head positioning. Retinal detachment in eyes with combined retinal inferior and superior breaks may have a lower success rate, and whether this is due to lack of postoperative positioning needs further evaluation in prospective, controlled studies.

Internal Limiting Membrane Transposition for Persistent Macular Holes Using Double Layers of Viscoelastic.

Internal limiting membrane (ILM) grafting provides a useful option for repair of large and refractory macular holes that fail to close following prior ILM removal. However, current ILM graft techniques are associated with several challenges that may result in failure, most notably the difficulty in maintaining the graft in situ. In this video, the authors describe their modified technique for ILM grafting using a double layer of viscoelastic for stabilization in situ during the procedure. Four of five eyes managed with this technique demonstrated type 1 closure, and all eyes demonstrated improvement in visual acuity.

Macular hole repair with limited nonsupine positioning.

PURPOSE: To assess the surgical success rates of modern macular hole repair with elimination of face down positioning. METHODS: A review of data for 72 eyes (from 102 consecutive cases) with idiopathic macular holes treated surgically between 1998 and 2004 was performed. Exclusion criteria consisted of macular hole for >1 year or of unknown duration and macular holes from secondary causes. All patients were evaluated and surgically managed by one surgeon (R.T.). RESULTS: Average preoperative best spectacle corrected visual acuity (BSCVA) was 20/170 (6/51). Six patients had a grade II hole, 60 patients had a grade III hole, and 6 patients, had a grade IV hole. Anatomical success was achieved in 92% of cases with 1 operation, and the average postoperative BSCVA was 20/46 (6/14). Six patients required additional surgical management to achieve anatomical success with an average postoperative BSCVA of 20/55 (6/16.5). The postoperative BSCVA improved an average of 5.7 lines from baseline. CONCLUSION: Favorable anatomical and BSCVA outcomes were achieved with the elimination of face down positioning in the postoperative period. Additional benefits are an increase in patient acceptance and compliance and the number of patients eligible for the procedure.