MANAGEMENT OF LARGE FULL-THICKNESS MACULAR HOLES: Long-Term Outcomes of Internal Limiting Membrane Flaps and Internal Limiting Membrane Peels.

BACKGROUND/PURPOSE: To determine and compare the efficacy of a surgical internal limiting membrane (ILM) flap technique with the traditional ILM peel on long-term visual and anatomical outcomes for large (>400 µm) full-thickness macular holes. METHODS: From October 2016 to July 2022, patients undergoing initial full-thickness macular hole repair with the ILM flap or ILM peel technique were reviewed. Final outcomes were recorded and based on size in microns: 401 to 800, 801 to 1,200, and >1,200. RESULTS: Patients treated with ILM flap (n = 52, 94.2% closure rate) or ILM peel (n = 407, 93.6% closure rate) were followed with a mean follow-up time of 15.0 ± 10.2 and 20.0 ± 13.4 months, respectively. Success rates for ILM flaps and ILM peels were compared for full-thickness macular holes of 401 to 800 (100%, 95.8%, P = 0.39), 801 to 1,200 (95%, 93%, P = 0.74), and >1,200 (86.7%, 86.7%, P = 1.0) µm. Mean best-recorded logarithm of the minimal angle of resolution visual acuity for ILM flaps and ILM peels, respectively, was 1.02 ± 0.46 and 0.87 ± 0.47 preoperatively, with follow-up acuity of 0.48 ± 0.32 (P < 0.03) and 0.39 ± 0.42 (P < 0.01) at Year 3. CONCLUSION: Both techniques provide a similar anatomical closure rate and functional improvement in vision. Comparisons should be cautiously made based on difference in preoperative hole size.

Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial.

PURPOSE: To study the efficacy and safety of suprachoroidal CLS-TA (proprietary suspension of triamcinolone acetonide) in uveitic macular edema (UME) with and without concurrent systemic corticosteroid or steroid-sparing therapy (ST). METHODS: Post hoc analysis of the PEACHTREE phase 3 randomized trial. RESULTS: Among UME patients receiving no ST, at week 24, mean BCVA change was +15.6 letters in 68 CLS-TA patients versus +4.9 letters in 49 sham-control patients (p < .001), while mean CST change was -169.8 µm versus -10.3 µm, respectively (p < .001). Among patients receiving ST, at week 24, mean BCVA change was +9.4 letters in 28 CLS-TA patients versus -3.2 letters in 15 sham-control patients (p = .019), while mean CST change was -108.3 µm versus -43.5 µm, respectively (p = .190). No SAEs related to treatment were reported. CONCLUSIONS: A clinically meaningful benefit of CLS-TA was noted in UME patients, regardless of concurrent ST usage.Abbreviation and AcronymsCST = central subfield thickness; BCVA = best corrected visual acuity; ME = macular edemaI; IVT = intravitreal; AE = adverse event; FA = fluocinolone acetonide; SD-OCT = spectral-domain optical coherence tomography; NIU = noninfectious uveitis; SAE = serious adverse event; TEAE = treatment emergent adverse event; ITT = intent to treat; CI = confidence interval.

Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies.

INTRODUCTION: Macular edema, a common complication of uveitis, may result in vision loss. The aim of this analysis was to report integrated phase 3 trial data for triamcinolone acetonide injectable suspension for suprachoroidal use (SCS-TA) in the treatment of macular edema secondary to noninfectious uveitis using strict inclusion criteria. METHODS: This analysis included patients with central subfield thickness (CST) ≥ 300 µm and best-corrected visual acuity (BCVA) of ≥ 5 and ≤ 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at both screening and baseline who received ≥ 1 study treatment in either PEACHTREE (randomized, double-masked SCS-TA or sham control) or AZALEA (open-label SCS-TA). Patients received SCS-TA 4.0 mg (0.1 ml of 40 mg/ml) or control at baseline and week 12. RESULTS: In the SCS-TA group (n = 95), 47.4% of patients gained ≥ 15 ETDRS letters from baseline to week 24 versus 16.7% of patients in the control group (n = 60; P < 0.001). Mean change in BCVA in the SCS-TA group was 9.6 letters at week 4 and 13.9 letters at week 24. CST also improved rapidly in the SCS-TA group (mean change: - 158.4 µm at week 4), with sustained reduction throughout the study (mean change: - 163.9 µm at week 24 versus - 19.3 µm in the control group; P < 0.001). No treatment-related serious adverse events (AEs) were reported. Incidence of AEs pertaining to elevated intraocular pressure was 12.6% and 15.0% in the SCS-TA and control groups, respectively; incidence of cataract formation/worsening AEs was 7.4% and 6.7%, respectively. CONCLUSION: In this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02595398, NCT03097315.

Clinical Characterization of Suprachoroidal Injection Procedure Utilizing a Microinjector across Three Retinal Disorders.

Purpose: This study assessed physician-investigator experience with suprachoroidal (SC) injections, an investigational therapeutic administration technique using a 900 or 1100 µm microneedle to inject drugs into the SC space. Methods: Datasets from six clinical trials across three diseases (noninfectious uveitis; diabetic macula edema, and retinal vein occlusion) were assessed. In addition to a user survey, retrospective correlations were performed between procedural variables (needle length), and demographics, and ocular characteristics. Results: In the user survey, 84% (31/37) of physician-investigators did not perceive the SC injections to be meaningfully more challenging than other ocular injections. For the correlation analysis, the 900 µm needle was used for 71% (412/581) of baseline injections, and switching to the longer needle occured in the remaining 29% of baseline injections. No statistical correlations were found between needle lengths and age, race, disorder, refraction, visual acuity, intraocular pressure, retinal central subfield thickness, or lens status. Patient gender and needle length were statistically associated, with 76% (210/275) versus 66% (202/306) of injections administered with 900 µm needles for female and male gender, respectively. Injection quadrant correlated to needle length with 78% (214/275) of superotemporal quadrant injections administered with 900 µm needles, compared with 65% (73/113) of inferotemporal quadrant injections. Conclusions: Both the user survey and the correlation analysis demonstrated that SC injection is well accepted by physician-investigators, and the two needle lengths accommodate a wide range of anatomic and demographic variables. Translational Relevance: These results, along with the presented ex-vivo endoscopic imaging, suggest that SC injection could be readily adopted in clinical practice for targeted compartmentalized delivery of ocular therapeutics.

Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to Noninfectious Uveitis: Phase 3 Randomized Trial.

PURPOSE: Injection of pharmacotherapy into the suprachoroidal space, between the sclera and choroid, is an alternative delivery technique developed with the rationale of providing higher drug concentrations to posterior ocular structures compared with other intraocular and periocular injection procedures. This study was conducted to evaluate the safety and efficacy of suprachoroidally injected triamcinolone acetonide formulation (CLS-TA), a suspension of triamcinolone acetonide, in improving vision among patients with noninfectious uveitis complicated by macular edema (ME). DESIGN: Phase 3 masked, randomized trial. PARTICIPANTS: One hundred sixty patients with ME secondary to noninfectious uveitis. Patients were required to have a best-corrected visual acuity (BCVA) of 5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 20/40) in the study eye. METHODS: Patients were randomized 3:2 to suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 and week 12. MAIN OUTCOME MEASURES: The primary end point was improvement from baseline of 15 or more ETDRS letters in BCVA at week 24. The secondary end point was reduction from baseline in central subfield thickness (CST) at week 24. RESULTS: In the CLS-TA arm, 47% of patients gained 15 or more ETDRS letters in BCVA versus 16% in the control arm (P < 0.001), meeting the primary end point. Mean reductions in CST from baseline were 153 µm versus 18 µm (P < 0.001). No serious adverse events (AEs) related to treatment were reported. Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% and 15.6% of the CLS-TA and control groups, respectively. Cataract AE rates were comparable (7.3% and 6.3%, respectively). CONCLUSIONS: Patients in the CLS-TA study arm experienced clinically significant improvement in vision relative to the sham procedure, demonstrating the efficacy of suprachoroidal injection of CLS-TA for the treatment of ME in a vision-threatening disorder.

ACUTE MACULAR NEURORETINOPATHY IN SUSAC SYNDROME: A NEW ASSOCIATION.

PURPOSE: To report a case of acute macular neuroretinopathy in a patient with Susac syndrome. METHODS: Case report. RESULTS: A 39-year-old male patient presented with severe headache, photopsias, and a sudden onset of hearing loss in the right ear. Fluorescein angiography of the right eye revealed multiple branch retinal artery occlusions. Clinical presentation of encephalopathy, hearing loss, and branch retinal artery occlusions, along with characteristic magnetic resonance imaging findings, led to a diagnosis of Susac syndrome. Despite aggressive immunosuppression for four months, the patient later presented with acute macular neuroretinopathy in the left eye. CONCLUSION: Acute macular neuroretinopathy and Susac is a new association of two well-defined disorders. The concurrence of both disorders supports retinal ischemia as the proximate cause of acute macular neuroretinopathy and inflammation as a potential etiology.

Office-based intravitreal injection of expansile gas for management of macular hole in previously vitrectomized eyes.

PURPOSE: To report the successful closure of full-thickness macular hole (MH), using an office-based intravitreal gas injection, in two eyes having undergone prior pars plana vitrectomy (PPV). OBSERVATIONS: Patient 1 presented with acute loss of visual acuity to 20/300 in the left eye 5 months following PPV for fovea-off rhegmatogenous retinal detachment; MH was confirmed by examination and optical coherence tomography (OCT). 0.6 cc of 100% C3F8 gas was injected, with subsequent MH closure following one week of face-down positioning. Patient 2 presented with right eye visual acuity of 20/60 one month following PPV for optic nerve pit-associated maculopathy; MH was confirmed by examination and OCT. 0.85 cc of 100% C3F8 gas was injected in the office, with subsequent MH closure following one week of face-down positioning. CONCLUSIONS AND IMPORTANCE: MH management in previously vitrectomized eyes has traditionally been repeat PPV with internal limiting membrane peeling, fluid-air exchange, and expansile gas exchange. Intravitreal gas injection, in an office-based setting, is a viable clinical approach to close MH in some previously vitrectomized eyes.

Clinical outcomes of 4-point scleral fixated 1-piece hydrophobic acrylic equiconvex intraocular lens using polytetrafluoroethylene suture.

PURPOSE: To report the visual outcomes and complications of scleral fixated intraocular lenses (IOLs) using Gore-Tex suture. METHODS: The current study is a retrospective noncomparative case series including patients who underwent scleral fixation of IOL (Akreos AO60) using Gore-Tex suture from August 2015 to March 2017 at a university teaching center. Primary outcome measures were visual acuity and complications at last follow-up. RESULTS: The current study included 49 eyes of 48 patients. Mean follow-up duration postsurgery was 6.9 months (range: 0.9-29.4 months). The indications for secondary IOL surgery were dislocated IOL in 16/49 (33%), subluxed IOL in 9/49 (18%), dislocated or subluxed crystalline lens in 9/49 (18%), traumatic cataract in 8/49 (16%), and complicated cataract surgery in 7/49 (14%). Mean best-corrected logMAR visual acuity improved from 1±0.7 (20/200 Snellen equivalent) preoperatively to 0.5±0.5 (20/63 Snellen equivalent) at last follow-up. There were no intraoperative complications noted. Early postoperative complications included significant persistent corneal edema (longer than 1 week) in 4/49 (8.2%), ocular hypertension (intraocular pressure ≥25 mmHg) in 8/49 (16.3%), hypotony (intraocular pressure ≤5 mmHg) in 6/49 (12.2%), cystoid macular edema 3/21 (6.1%), IOL tilt 2/49 (4.1%), hyphema in 2/49 (4.1%), and vitreous hemorrhage in 5/49 (4.8%). There was one case of recurrent retinal detachment. One patient presented with an erosion of the Gore-Tex suture through the conjunctiva resulting in a purulent scleritis 6 months after the initial surgery, and was managed with removal of the IOL, debridement, and cryotherapy. Forty-one of 49 patients completed 3-month follow-up, among which visual acuity improved, deteriorated, or remained same compared to baseline in 27/49 (55.1%), 8/49 (16.3%), and 6/49 (12.2%) eyes, respectively. CONCLUSION: In the current study, visual acuity outcomes were generally favorable. The complications were largely transient. Significant complications included a suture-related infection, which required removal of the IOL, and a recurrence of a retinal detachment.

Pars Plana Vitrectomy for the Treatment of Uveitis.

PURPOSE: To review and summarize evidence in the medical literature regarding the use of pars plana vitrectomy in the management of uveitis. DESIGN: Systematic literature review. METHODS: A systematic literature search was conducted for relevant articles on pars plana vitrectomy for the management of uveitis. Results from the studies were compiled and analyzed. RESULTS: Thirty-four articles, published from 2005 through 2014, were included in the final data analysis. Thirty-two manuscripts were from retrospective case series and 2 manuscripts were from randomized pilot studies. The median Scottish Intercollegiate Guidelines Network level of evidence grade was 3 and the median Oxford Center for Evidence-based Medicine level of evidence grade was 4. Fewer than 50% of the articles in the current study applied Standardization of Uveitis Nomenclature (SUN) criteria in regard to reporting the anatomic location of uveitis, fewer than 25% of studies applied SUN criteria in regard to the reporting of anterior chamber cells before and after PPV, fewer than 10% of studies applied SUN criteria to the grading of anterior chamber flare before and after PPV, and fewer than 10% of studies applied standardized criteria to the grading of vitreous haze after PPV. Overall, 627 patients and 708 total eyes undergoing PPV for uveitis were included. The average reported age of all patients was 43.4 years. The median duration of uveitis prior to PPV reported in the studies was 36.1 months (range 4-198 months). The median follow-up after PPV reported in the studies was 18.9 months (range 2-114 months). Vision was reported for 519 eyes and was improved in 356 eyes (69%), unchanged in 95 eyes (18%), and worse in 68 eyes (13%) following PPV. Preoperatively, 157 of 300 (52%) eyes in these studies had documented cystoid macular edema compared to 112 of 300 (37%) postoperatively. Median use of oral corticosteroids improved from 48% preoperatively to 12% postoperatively among the reporting studies. Median use of other immunosuppressive medications decreased from 56% preoperatively to 36% postoperatively among the reporting studies. CONCLUSIONS: Although nearly all studies continue to report favorable outcomes of PPV in the management of uveitis, the quality of data remains limited by a lack of application of standardized reporting outcomes, limitations in study design, and a paucity of prospective data.

The importance of vision.

Based on a systematic review and meta-analysis of 8 studies, involving 2,559 subjects, both interventional cardiologists (3.21) and cardiac cath lab staff (2.76) had a significantly higher relative risk of posterior lens opacity than the control group. It is essential to provide "best practice" in radiation dose management and lead shielding in the cath lab with the standard "As Low As Reasonably Achievable"! There is a clear need for better data to quantitate the radiation risk and to design innovative strategies to decrease that risk.

Chorioretinal Lesions Presumed Secondary to Zika Virus Infection in an Immunocompromised Adult.

IMPORTANCE: Zika virus has spread rapidly throughout the Americas since 2015. The public health implications of Zika virus infection lend special importance to identifying the virus in unsuspected hosts. OBJECTIVE: To describe relevant imaging studies and clinical features of chorioretinal lesions that are presumably associated with Zika virus and that share analogous features with chorioretinal lesions reported in cases of Dengue fever and West Nile virus. DESIGN, SETTING, AND PARTICIPANTS: This is a case report from an academic referral center in Miami, Florida, of a woman in her 60s from Guaynabo, Puerto Rico, who presented with reduced visual acuity and bilateral diffuse, subretinal, confluent, placoid, and multifocal chorioretinal lesions. The patient was observed over a 5-month period. MAIN OUTCOMES AND MEASURES: Visual acuity, clinical course, and multimodal imaging study results. RESULTS: Fluorescein angiography revealed early hypofluorescence and late staining of the chorioretinal lesions. Optical coherence tomography demonstrated outer retinal disruption in the placoid macular lesions. Zika RNA was detected in a plasma sample by real-time reverse transcription polymerase chain reaction testing and was suspected to be the cause of chorioretinal lesions after other viral and infectious causes were ruled out. Three weeks after the onset of symptoms, the patient's visual acuity had improved to 20/60 OD and 20/25 OS, with intraocular pressures of 18 mm Hg OD and 19 mm Hg OS. In 6 weeks, the chorioretinal lesions had healed and visual acuity had improved to 20/25 OD and 20/20 OS. Follow-up optical coherence tomography demonstrated interval recovery of the outer retina and photoreceptors. CONCLUSIONS AND RELEVANCE: Acute-onset, self-resolving, placoid, or multifocal nonnecrotizing chorioretinal lesions may be a feature of active Zika virus chorioretinitis, as reported in other Flavivirus infections in adults. Similar findings in potentially exposed adults suggest that clinicians should consider IgM antibody or polymerase chain reaction testing for Zika virus as well as diagnostic testing for Dengue fever and West Nile virus.

Role of steroids in the treatment of bacterial keratitis.

Bacterial keratitis can lead to severe visual impairment from corneal ulceration, subsequent scarring, and possible perforation. The mainstay of treatment is topical antibiotics, whereas the use of adjunctive topical corticosteroid drops remains a matter of debate. Herein, we review the rationale for and against the use of topical corticosteroids and we assess their effectiveness and safety in the published randomized controlled trials that have evaluated their role as adjunctive therapy for bacterial corneal ulcers. In the largest study to date, the Steroids for Corneal Ulcers Trial, topical corticosteroid drops were neither helpful nor harmful for the 500 participants as a whole. However, subgroup analyses suggested that topical corticosteroids may be beneficial upon early administration (within 2-3 days after starting antibiotics) for more central corneal ulcers with poorer vision at presentation, for invasive Pseudomonas strains, and for non-Nocardia ulcers. These results are discussed within the limitations of the study.

Long-term follow-up of intravitreal bevacizumab for the treatment of pediatric retinal and choroidal diseases.

PURPOSE: To describe the long-term outcomes of intravitreal bevacizumab (IVB) for the treatment of pediatric retinal and choroidal diseases. METHODS: This was a multicenter, retrospective, consecutive case series of patients <18 years of age treated with IVB from 2005 to 2013. Primary outcome measures included visual acuity and central macular thickness at 12 months' follow-up. RESULTS: A total of 95 eyes of 90 patients (average age, 8.7 years [range, 0.33-17 years]) were included, in which 352 injections (average, 3.7/eye) were administered for choroidal neovascular membrane (CNVM, n = 35), Coats disease (n = 35), familial exudative vitreoretinopathy (FEVR, n = 13), cystoid macular edema (CME, n = 6), and other (n = 6). Mean follow-up was 679 ± 581 days. IVB was used as monotherapy in 27 eyes and as part of combination therapy in 68. Mean Snellen equivalent visual acuity improved from 20/224 at baseline to 20/120 at 6 months (P = 0.034) and 20/108 at 12 months (P = 0.005). Mean central macular thickness improved from 426 µm to 349 µm at 6 months (P = 0.025) and 340 µm at 12 months (P = 0.002). Statistically significant visual acuity gains at 12 months were achieved in patients with CNVM (P = 0.009) but not in eyes with CME (P = 0.06), Coats disease (P = 0.15), or FEVR (P = 0.93). Adverse effects included ocular hypertension in 8 eyes and worsening tractional retinal detachment in 3 eyes. CONCLUSIONS: Patients receiving IVB as part of the treatment for pediatric retinal and choroidal diseases experienced significant visual acuity gains and reductions in central macular thickness. IVB was generally well tolerated, although safety concerns persist.

Diagnostic Sensitivity of Indocyanine Green Angiography for Birdshot Chorioretinopathy.

IMPORTANCE: To describe a cohort of patients with birdshot chorioretinopathy who did not manifest birdshot lesions on clinical examination but had retinal vasculitis, low-grade to moderate vitritis, and hypocyanescent lesions on indocyanine green angiography (ICGA). OBSERVATIONS: Case series of 3 patients with mild to moderate vitritis and retinal vasculitis without definite birdshot lesions on clinical examination evaluated from January 2007 to December 2014 at 4 academic ophthalmology centers. All patients' results were positive for human leukocyte antigen-A29. All cases had hypocyanescent lesions visible on ICGA but not detectable on fluorescein angiography. CONCLUSIONS AND RELEVANCE: Patients with retinal vasculitis and low-grade vitritis with or without macular edema may have birdshot chorioretinopathy evident on ICGA before lesions are visible on clinical examination or fluorescein angiography. Expanding birdshot chorioretinopathy diagnostic criteria to include the presence of hypocyanescent lesions on ICGA could improve the sensitivity of diagnosis.

Endophthalmitis following pars plana vitrectomy for vitreous floaters.

A case of Staphylococcus caprae endophthalmitis in a young patient following pars plana vitrectomy for symptomatic vitreous floaters is reported here. Recent literature suggests that there is an increasing trend of performing pars plana vitrectomy for symptomatic floaters. Although rare, the potential risk of endophthalmitis should be explicitly discussed with patients considering surgical intervention for vitreous floaters.

Successful treatment of juvenile xanthogranuloma using bevacizumab.

Juvenile xanthogranuloma (JXG) is an uncommon non-Langerhans cell histiocytic disorder that occurs predominantly in infants. Traditional treatment of ocular JXG involves the administration of topical or local corticosteroids. We treated 2 children with JXG refractory to local corticosteroid therapy with off-label intraocular bevacizumab. To our knowledge, this is the first report of successful use of bevacizumab for ocular JXG.