Purpose To measure foveal avascular zone (FAZ) dimensions in healthy eyes using optical coherence tomography angiography (OCTA) and calculate interobserver variability. Design Reliability analysis. ...Methods Thirty-four eyes of 17 healthy subjects underwent OCTA at the Retina Service of Wills Eye Hospital. Two masked graders performed measurements of FAZ dimensions including area, perimeter, and maximum horizontal and vertical diameters using ImageJ. Intraclass correlation coefficient (ICC) between graders was calculated. Results Mean area (mm2 ), perimeter (mm), and maximum horizontal and vertical diameters (mm) were 0.27 ± 0.101, 2.21 ± 0.451, 0.59 ± 0.126, and 0.56 ± 0.118, respectively, at the superficial and 0.34 ± 0.116, 2.50 ± 0.462, 0.69 ± 0.123, and 0.63 ± 0.110 at the deep network. Interobserver agreement was high for all superficial FAZ measurements (ICC ≥0.90) but did not meet the lowest acceptable grader agreement for the deep vascular network (ICC <0.85). Fellow eyes had statistically similar values ( P > .05). Conclusion Manual measurement of FAZ dimensions using OCTA is a noninvasive and reliable method for quantifying FAZ at the superficial vascular network. Assessing FAZ alterations in the deep vascular network may be subject to greater interobserver variability.
To quantify foveal avascular zone (FAZ) area and macular vascular density objectively using optical coherence tomography angiography (OCTA) and to examine correlations with visual acuity in eyes with ...diabetic retinopathy (DR) in the absence of diabetic macular edema.
Retrospective observational case series.
Eighty-four eyes from 55 patients with DR and 34 control eyes from 27 age-matched healthy participants.
All eyes underwent OCTA (RTVue-XR Avanti; Optovue, Inc, Fremont, CA). Integrated automated algorithms were used to quantify FAZ area and macular vascular density.
FAZ area, vessel area density (VAD), vessel length density (VLD), and visual acuity.
In each study eye, DR was classified as mild nonproliferative DR (NPDR; n = 32 38%), moderate-to-severe NPDR (n = 31 37%), or proliferative DR (n = 21 25%). Mean FAZ area was greater in diabetic eyes compared with control eyes both in the superficial (0.427 mm
vs. 0.275 mm
; P < 0.001) and deep (0.616 mm
vs. 0.372 mm
; P < 0.001) vascular networks. Mean VAD was lower in diabetic eyes compared with control eyes in both the superficial (49.44% vs. 55.09%; P < 0.001) and deep (56.65% vs. 61.32%; P < 0.001) networks. Mean VLD was also lower in diabetic eyes compared with control eyes in both the superficial (17.68 mm
vs. 21.55 mm
; P < 0.001) and deep (21.19 mm
vs. 24.38 mm
; P < 0.001) networks. In all eyes, there was a statistically significant negative correlation between the logarithm of the minimum angle of resolution (logMAR) visual acuity and the vascular density in both the superficial (VAD, ρ = -0.52; VLD, ρ = -0.54; P < 0.001) and deep (VAD, ρ = -0.50; VLD, ρ = -0.50; P < 0.001) networks. A positive correlation was found between logMAR visual acuity and FAZ area in both the superficial (ρ = 0.29; P < 0.01) and deep (ρ = 0.48; P < 0.001) networks.
Automated quantitative algorithms allow for objective assessment of retinal vascular changes in eyes with DR that are correlated to visual acuity. These methods may prove useful in monitoring disease progression and identifying parameters that affect visual function.
Abstract Purpose To quantify density of macular vascular networks over regions of interest in healthy subjects using optical coherence tomography angiography (OCTA). Design Prospective ...cross-sectional study. Methods Settings: Retina and Oncology Services of Wills Eye Hospital. Subjects with no known systemic disease and without retinal pathology were included. OCTA was performed on a 3×3-mm region centered on the macula (RTVue-XR Avanti, Optovue) and en face angiograms of the superficial and deep vascular networks were acquired. Vascular density was calculated using an automated image thresholding method (ImageJ, National Institutes of Health) over regions of interest. Foveal and parafoveal vascular density were calculated. The differences between vascular networks, genders, fellow eyes and correlation between vascular density, signal strength, and age as well as reproducibility of measurements were evaluated. Results A total of 198 healthy eyes were imaged from which 163 eyes of 122 subjects were included based on image quality criteria. In the parafoveal region, deep vascular density was significantly higher than the superficial (52±2.4% vs. 46±2.2%; P< 0.001) whereas the opposite was found in the foveal region (27±5.2% vs. 32±3.2%; P< 0.001). All vascular density measurements were statistically similar in fellow eyes and there was no gender difference ( P >0.05). There was a negative correlation between vascular density and age that persisted upon adjusting for signal strength. Vascular density measurements were highly correlated between separate imaging sessions with intraclass correlation coefficients of over 0.85 for all assessments. Conclusions Calculation of vascular density using OCTA is a reproducible and non-invasive method to quantitate individual networks within the macula. Understanding normal values and their correlations could affect clinical evaluation of the macula in healthy patients and disease states.
Terson’s Syndrome Durrani, Asad; Ho, Allen C.
The New England journal of medicine,
06/2023, Letnik:
388, Številka:
25
Journal Article
Recenzirano
A 41-year-old man who had had a subarachnoid hemorrhage 10 years earlier presented with a 2-day history of blurred vision and throbbing headache. Nondilated funduscopic examination revealed ...multilayered hemorrhages in both eyes.
Abstract Purpose To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome. Design Post-hoc analysis of ...randomized-controlled-trial data Methods Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network’s Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52‒156) visual acuity response mean change from baseline in best-corrected visual acuity (CFB BCVA); categorized improvement (<5, 5‒9, or ≥10 Early Treatment Diabetic Retinopathy Study ETDRS letters) in BCVA. Results In the analysis population (340 eyes), <5, 5‒9, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2% and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5% and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5‒9, and ≥10 letter- improvement at 12 weeks), mean CFB BCVA at 52‒156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders. Conclusions Ranibizumab ± laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).
This study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration.
Single-arm, prospective, ...multicenter clinical trial.
Thirty subjects were enrolled in the United States and Europe between June 6, 2007, and August 11, 2009. All subjects were followed up for a minimum of 6 months and up to 2.7 years.
The electronic stimulator and antenna of the implant were sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed, and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array then was tacked to the epiretinal surface.
The primary safety end points for the trial were the number, severity, and relation of adverse events. Principal performance end points were assessments of visual function as well as performance on orientation and mobility tasks.
Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications.
The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it.
Assess 12-month efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after branch retinal vein occlusion (BRVO).
Prospective, randomized, sham ...injection-controlled, double-masked, multicenter trial.
A total of 397 patients with macular edema after BRVO.
Eligible patients were randomized 1:1:1 to 6 monthly injections of 0.3 mg or 0.5 mg ranibizumab or sham injections. After 6 months, all patients with study eye best-corrected visual acuity (BCVA) ≤20/40 or central subfield thickness ≥250 μm were to receive ranibizumab. Patients could receive rescue laser treatment once during the treatment period and once during the observation period if criteria were met.
The main efficacy outcome reported is mean change from baseline BCVA letter score at month 12. Additional visual and anatomic parameters were assessed.
Mean (95% confidence interval) change from baseline BCVA letter score at month 12 was 16.4 (14.5-18.4) and 18.3 (15.8-20.9) in the 0.3 mg and 0.5 mg groups, respectively, and 12.1 (9.6-14.6) in the sham/0.5 mg group (P<0.01, each ranibizumab group vs. sham/0.5 mg). The percentage of patients who gained ≥15 letters from baseline BCVA at month 12 was 56.0% and 60.3% in the 0.3 mg and 0.5 mg groups, respectively, and 43.9% in the sham/0.5 mg group. On average, there was a marked reduction in central foveal thickness (CFT) after the first as-needed injection of 0.5 mg ranibizumab in the sham/0.5 mg group, which was sustained through month 12. No new ocular or nonocular safety events were identified.
At month 12, treatment with ranibizumab as needed during months 6-11 maintained, on average, the benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after BRVO, with low rates of ocular and nonocular safety events. In the sham/0.5 mg group, treatment with ranibizumab as needed for 6 months resulted in rapid reduction in CFT to a similar level as that in the 0.3 mg ranibizumab treatment group and an improvement in BCVA, but not to the extent of that in the 2 ranibizumab groups. Intraocular injections of ranibizumab provide an effective treatment for macular edema after BRVO.
Proprietary or commercial disclosure may be found after the references.
The prevalence of diabetic retinopathy continues to rise. This review highlights advances in imaging, medical, and surgical management of proliferative diabetic retinopathy (PDR) in recent years.
...Ultra-widefield fluorescein angiography has been shown to better characterize which patients have predominantly peripheral lesions and who may advance to more advanced forms of diabetic retinopathy. This was well demonstrated in DRCR Retina Network's Protocol AA. Protocol S demonstrated that antivascular endothelial growth factor (VEGF) treatment alone can be useful in the management of select PDR patients - particularly those without high-risk features. However, a growing body of literature highlights how lapse in care is a significant concern in PDR patients, and tailoring one's approach to treatment based on patient needs is recommended. In patients with high-risk features or where there is concern for lost-to-follow-up, incorporation of panretinal photocoagulation in the treatment paradigm is recommended. Protocol AB highlighted how patients with more advanced disease may benefit from earlier surgical intervention for earlier visual recovery but that continued anti-VEGF treatment may result in similar visual outcomes over a longer period. Finally, earlier surgical intervention for PDR without vitreous hemorrhage (VH) or retinal detachment is being considered a potential option to minimize treatment burden.
Recent advances in imaging, as well as medical and surgical treatment options for PDR, have provided a deeper understanding of PDR management, which can be optimized for the individual patient.
To evaluate the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients with subfoveal neovascular ...age-related macular degeneration (wet AMD).
A 24-month, phase III, randomized, multicenter, double-masked, dose-response study.
Patients aged ≥50 years with subfoveal wet AMD.
Patients (n = 1098) were randomized to receive ranibizumab 0.5 mg or 2.0 mg intravitreal injections administered monthly or on a PRN basis after 3 monthly loading doses.
The primary efficacy end point was the mean change from baseline in best-corrected visual acuity (BCVA) at month 12. Key secondary end points included the mean number of ranibizumab injections, the mean change from baseline in central foveal thickness (CFT) over time, and the proportion of patients who gained ≥15 letters of BCVA. Unless otherwise specified, end point analyses were performed using the last-observation-carried-forward method to impute missing data.
At month 12, the mean change from baseline in BCVA for the 4 groups was +10.1 letters (0.5 mg monthly), +8.2 letters (0.5 mg PRN), +9.2 letters (2.0 mg monthly), and +8.6 letters (2.0 mg PRN). The proportion of patients who gained ≥15 letters from baseline at month 12 in the 4 groups was 34.5%, 30.2%, 36.1%, and 33.0%, respectively. The mean change from baseline in CFT at month 12 in the 4 groups was −172.0 μm, −161.2 μm, −163.3 μm, and −172.4 μm, respectively. The mean number of injections was 7.7 and 6.9 for the 0.5-mg PRN and 2.0-mg PRN groups, respectively. Ocular and systemic safety profiles were consistent with previous ranibizumab trials in AMD and comparable between groups.
At month 12, the ranibizumab 2.0 mg monthly group did not meet the prespecified superiority comparison and the ranibizumab 0.5 mg and 2.0 mg PRN groups did not meet the prespecified noninferiority (NI) comparison. However, all treatment groups demonstrated clinically meaningful visual improvement (+8.2 to +10.1 letters) and improved anatomic outcomes, with the PRN groups requiring approximately 4 fewer injections (6.9–7.7) than the monthly groups (11.2–11.3). No new safety events were observed despite a 4-fold dose escalation in the study. The pHase III, double-masked, multicenter, randomized, Active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg Ranibizumab administered monthly or on an as-needed Basis (PRN) in patients with subfoveal neOvasculaR age-related macular degeneration (HARBOR) study confirmed that ranibizumab 0.5 mg dosed monthly provides optimum results in patients with wet AMD.
Proprietary or commercial disclosure may be found after the references.
The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer ...retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.
Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II.
Thirty participants in 10 centers in the United States and Europe.
The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.
The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks.
Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.
The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.
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