DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM).
METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice.
RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities.
CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.
DESIGN: Case report.
METHODS: An 18-year-old man presented with sudden loss of vision in the right eye following competitive swimming. He was found to have a massive subretinal hemorrhage involving the macula.
RESULTS: Following resolution of the hemorrhage, the patient was found to have an underlying choroidal osteoma. There was no evidence of choroidal neovascularisation clinically and angiographically. He regained his normal vision.
CONCLUSIONS: Choroidal osteoma presenting with massive subretinal hemorrhage not associated with underlying choroidal neovascularization need not result in poor visual outcome.
METHODS: This prospective clinical study included consecutive Asian patients with dark irides and confirmed for glaucoma. Only one eye of each patient was treated. Diode laser contact transscleral cyclophotocoagulation treatment was performed with the center of the probe placed 1.5 mm behind the limbus. About 30 pulses of 810-mm laser radiation (power, 1.8 to 2.0 W; duration, 0.3 to 0.5 second) were applied around the eye. Patients were examined at fixed postoperative intervals. Intraocular pressure levels and postoperative complications were recorded. The relation between patient and disease characteristics, total laser energy delivered, and intraocular pressure effects were analyzed.
RESULTS: Thirty-three patients were studied, with a mean follow-up period of 9.4 months. An average 56% of patients showed a 30% or greater drop in intraocular pressure. About 38% of patients achieved sustained intraocular pressure lowering to below 22 mm Hg at 18 months. Complications were few and included transient hypotony and iritis.
CONCLUSIONS: In Asian patients with refractory glaucoma or painful glaucomatous eyes with poor visual acuity (defined for this study as worse than 20/200), low-energy-setting diode laser contact transscleral cyclophotocoagulation by means of the glass ball probe is relatively effective and safe.
DESIGN: Retrospective interventional case series.
METHODS: Thirty-nine eyes from 39 patients with a FTMH <600 μm were included from a single institution. All patients underwent vitrectomy using a semicircular single-layered ILM inverted flap assisted by a sub-perfluorocarbon liquid injection of ophthalmic viscoelastic device (OVD) technique. Best-corrected visual acuity (BCVA) and spectral domain optical coherence tomography were used to compare outcomes between nasal (n = 19) and temporal (n = 20) groups.
RESULTS: At 6 months postoperatively, all FTMHs closed and BCVA were significantly improved. Overall, 36 eyes (92%) achieved U-shaped closure, and ellipsoid zone restoration was noted in 24 eyes (62%). An ILM flap was present in 29 eyes (74%) and 86% remained single-layered. There were significantly more deep inner retinal dimples in the temporal group (35%) compared with 5% in the nasal group (P = .04), but these were unrelated to BCVA. Significant retinal thinning in the temporal outer sub-field was noted in the temporal group and was negatively correlated with BCVA (rho [ρ]: - .53; P = .03). No significant postoperative retinal displacement was noted in either group.
CONCLUSIONS: The technique of using sub-perfluorocarbon liquid injection of OVD secured single-layered flaps intraoperatively and postoperatively. Both the nasal and temporal inverted ILM flaps repaired FTMH and improved visual acuity. However, both temporal macular thinning and deep inner retinal dimples were significantly greater in the temporal group.
DESIGN: Multicenter retrospective case series.
METHODS: Retrospective review.
RESULTS: Seven patients presented with corneal findings ranging from superficial punctate epitheliopathy to bilateral corneal melt with subsequent perforation. Among those with mild corneal findings, resolution was achieved with topical steroids and lubrication, whereas some patients who developed progressive corneal melt required therapeutic penetrating keratoplasty. The history in all patients revealed exposure to aquarium zoanthid corals shortly before disease onset. A review of the literature revealed that there are few prior reports of coral-associated corneal toxicity and that some species of coral secrete a substance known as palytoxin, a potent vasoconstrictor that inhibits the membranous sodium-potassium ATPase pump across cell types and can cause rapid death if inhaled or ingested.
CONCLUSIONS: This is the largest case series to date demonstrating patients with aquarium coral palytoxin-associated corneal toxicity, and is the first to provide details of related histopathologic findings. Similar to other forms of toxic keratoconjunctivitis, a detailed history and careful clinical assessment are required, as well as timely removal of the offending agent from the patients' ocular milieu and environment. Mild ocular surface and corneal disease may be treated effectively with aggressive topical steroid therapy and lubrication. Given the potential severity of ocular as well as systemic adverse effects, there should be increased awareness of this entity among eye care professionals, aquarium enthusiasts, and the general public.
DESIGN: Prospective cross-sectional study.
METHODS: Consecutive CSC patients were recruited from retina clinic. The reference standard for CNV was determined by interpretation of multimodal imaging with OCTA, structural OCT line scan, fluorescein angiography (FA), indocyanine green angiography (ICGA), ultra-widefield fundus photography and fundus autofluorescence (FAF). Two independent masked graders examined OCTA without FA and ICGA to diagnose CNV. Univariate and multivariate analyses were performed to evaluate factors associated with CNV.
RESULTS: CNV was detected in 69 eyes in 64 out of 277 CSC patients according to reference standard. The two masked graders who examined OCTA had sensitivity of 81.2% (95% Confidence Interval [CI], 71.9%-90.4%) and 78.3% (95% CI, 68.5%-88.0%), specificity of 97.3% (95% CI, 95.9%-98.8%) and 96.2% (95% CI, 94.5%-98.0%), positive predictive values of 82.4% (95% CI, 73.3%-91.4%) and 76.1% (95% CI, 66.1%-86.0%), and negative predictive values of 97.1% (95% CI, 95.6%-98.7%) and 96.7% (95% CI, 95.0%-98.3%). Their mean area under the receiver operating characteristic curve (AUC) was 0.88 with good agreement (Kappa coefficient 0.80 [95% CI, 0.72-0.89]). Flat irregular pigment epithelial detachment on structural OCT, neovascular network on OCTA and ill-defined late leakage on FA significantly correlated with CNV in CSC from multiple regression (P < 0.001, P < 0.001 and P = 0.005, respectively).
CONCLUSIONS: There is discordance between OCTA and multimodal imaging in diagnosing CNV in CSC. This study demonstrated the caveats in OCTA interpretation, such as small extrafoveal lesions and retinal pigment epithelial alterations. Comprehensive interpretation of OCTA with dye angiography and structural OCT is recommended.
DESIGN: Double-masked, 100-week, multicenter, active-controlled, randomized trials.
METHODS: Subjects were randomized 1:1:1 to brolucizumab 3mg/6mg or aflibercept 2mg in KESTREL (N=566) or 1:1 to brolucizumab 6mg or aflibercept 2mg in KITE (N=360). Brolucizumab groups received 5 loading doses every 6 weeks (q6w) followed by q12w dosing, with optional adjustment to q8w if disease activity was identified at pre-defined assessment visits; aflibercept groups received 5xq4w 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 DRSS score and anatomical and safety outcomes.
RESULTS: At Week 52, brolucizumab 6mg was noninferior (NI margin 4 letters) to aflibercept in mean change in BCVA from baseline (KESTREL: +9.2 letters versus +10.5 letters; KITE: +10.6 letters versus +9.4 letters; p<0.001), more subjects achieved central subfield thickness (CSFT) <280µm and fewer had persisting subretinal and/or intraretinal fluid versus aflibercept, with >50% of brolucizumab 6mg subjects maintained on q12w dosing after loading. In KITE, brolucizumab 6mg showed superior improvements in change of CSFT from baseline over Week 40-Week 52 versus aflibercept (p=0.001). The incidence of ocular serious adverse events was 3.7% (brolucizumab 3mg), 1.1% (brolucizumab 6mg), 2.1% (aflibercept) in KESTREL; 2.2% (brolucizumab 6mg), 1.7% (aflibercept) in KITE.
CONCLUSION: Brolucizumab 6mg showed robust visual gains and anatomical improvements with an overall favorable benefit/risk profile in patients with DME.
DESIGN: Artificial intelligence (neural network) study.
METHODS: We assessed 1400 OCT scans of patients with neovascular AMD. Fifteen physical features for each eligible OCT, as well as patient age, were used as input data and corresponding recorded visual acuity as the target data to train, validate, and test a supervised neural network. We then applied this network to model the impact on acuity of defined OCT changes in subretinal fluid, subretinal hyperreflective material, and loss of external limiting membrane (ELM) integrity.
RESULTS: A total of 1210 eligible OCT scans were analyzed, resulting in 1210 data points, which were each 16-dimensional. A 10-layer feed-forward neural network with 1 hidden layer of 10 neurons was trained to predict acuity and demonstrated a root mean square error of 8.2 letters for predicted compared to actual visual acuity and a mean regression coefficient of 0.85. A virtual model using this network demonstrated the relationship of visual acuity to specific, programmed changes in OCT characteristics. When ELM is intact, there is a shallow decline in acuity with increasing subretinal fluid but a much steeper decline with equivalent increasing subretinal hyperreflective material. When ELM is not intact, all visual acuities are reduced. Increasing subretinal hyperreflective material or subretinal fluid in this circumstance reduces vision further still, but with a smaller gradient than when ELM is intact.
CONCLUSIONS: The supervised machine learning neural network developed is able to generate an estimated visual acuity value from OCT images in a population of patients with AMD. These findings should be of clinical and research interest in macular degeneration, for example in estimating visual prognosis or highlighting the importance of developing treatments targeting more visually destructive pathologies.