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Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.
Antoszyk, AN, Glassman, AR, Beaulieu, WT, Jampol, LM, Jhaveri, CD, Punjabi, OS, Salehi-Had, H, Wells, JA, Maguire, MG, Stockdale, CR, et al
JAMA. 2020;(23):2383-2395
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Abstract
IMPORTANCE Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown. OBJECTIVE To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020. INTERVENTIONS Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria. MAIN OUTCOMES AND MEASURES The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years. RESULTS Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, -5.0 [95% CI, -10.2 to 0.3], P = .06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, -11.2 [95% CI, -18.5 to -3.9], P = .003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, -3.1 to 8.4], P = .36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept. CONCLUSIONS AND RELEVANCE Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02858076.
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Reproducibility of Fixed-luminance and Multi-luminance Flicker Electroretinography in Patients With Diabetic Retinopathy Using an Office-based Testing Paradigm.
Wroblewski, JJ, McChancy, C, Pickel, K, Buterbaugh, H, Wieland, T, Gonzalez, A
Journal of diabetes science and technology. 2020;(6):1095-1103
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Abstract
BACKGROUND We evaluated the reproducibility of office-based flicker electroretinography (ERG) in patients with nonproliferative diabetic retinopathy (NPDR). METHODS An observational study was conducted in which ultra-widefield fluorescein angiography (UWF-FA) was performed on 20 patients with mild-to-moderate NPDR; images were graded by the Fundus Photography Reading Center (Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, WI, USA). Fixed- and multi-luminance flicker ERG was repeated four times (greater than or equal to seven days apart). Recording consistency was assessed using intra-class correlation coefficients (ICCs), coefficients of variation, and Pearson correlations. RESULTS 82.5% and 17.5% of eyes had mild and moderate NPDR using UWF-FA; 90% of the angiograms were given a high confidence grade. Fixed-luminance phase values were highly reproducible (ICC: 0.949; P < .001). There was a significant negative correlation between fixed-luminance phase and log-corrected ischemic index values (-0.426; P = .015). CONCLUSIONS Office-based, fixed-luminance phase values are highly reproducible and negatively correlate with retinal ischemia in NPDR, suggesting that global retinal dysfunction may be reliably quantified early in patients with diabetes.
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Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy-Related Macular Edema: 1-Year Outcomes.
Schefler, AC, Fuller, D, Anand, R, Fuller, T, Moore, C, Munoz, J, Kim, RS, ,
American journal of ophthalmology. 2020;:165-173
Abstract
PURPOSE To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy-related macular edema. DESIGN Phase IIb, prospective, randomized clinical trial. METHODS Setting: Multicenter. SUBJECTS Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent). INTERVENTION Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MainOutcomeMeasures: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline. RESULTS Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, -1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. CONCLUSIONS Ranibizumab may improve vision and anatomy in patients with radiation retinopathy-related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits.
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Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness.
Nemcansky, J, Stepanov, A, Nemcanska, S, Masek, P, Langrova, H, Studnicka, J
PloS one. 2019;(7):e0219282
Abstract
PURPOSE To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy during 12-month follow-up. METHODS The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method. RESULTS The performance of Pascal panretinal laser coagulation was evaluated as significantly less painful (visual scale of pain was 3.28 ± 1.9) than the performance of conventional photocoagulation (visual scale of pain was 3.93 ± 1.88) with similar efficiency. Distribution of progression of diabetic retinopathy in individual patients was very similar in both groups under comparison, and was strictly paired in 24 of the 30 patients at the end of 1-year follow-up. CONCLUSION Laser photocoagulation of the retina with the use of short impulse durations and patterns in patients with diabetic retinopathy given in one session possesses similar efficiency to that of conventional retinal photocoagulation in multiple sessions. The single session treatment is also better tolerated by patients and in addition to this, it shortens the performance of the whole therapy, which potentially saves considerable funds of all subjects participating in the process of treatment. TRIAL REGISTRATION ClinicalTrials.gov NCT03672656.
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OCT angiography-based monitoring of neovascular regression on fibrovascular membrane after preoperative intravitreal conbercept injection.
Hu, Z, Su, Y, Xie, P, Chen, L, Ji, J, Feng, T, Wu, S, Liang, K, Liu, Q
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2019;(8):1611-1619
Abstract
PURPOSE To quantify the preoperative neovascular change pattern on the fibrovascular membrane (FVM) within 7 days after intravitreal injection of conbercept (IVC) using optical coherence tomography angiography (OCTA) in proliferative diabetic retinopathy (PDR). METHODS Prospective, observational study of PDR patients with visible FVM receiving or not receiving IVC. Neovascular changes were assessed by OCTA pre-IVC and 1, 3, 5, and 7 days post-IVC. Vessel skeleton density (SD) and vessel density (VD) were quantified by an intensity-based optical microangiography algorithm. The interclass correlation coefficient (ICC) was calculated to assess the agreement between measurements. The SD and VD were compared between follow-ups using repeated-measures analysis in the IVC group. RESULTS The ICC was 0.992 (95% confidence interval [CI]: 0.982-0.996) for SD and 0.926 (95% CI: 0.838-0.912) for VD of neovascularization. The neovascularization on FVM significantly regressed in the IVC group (n = 16) compared with no IVC (n = 8) (p = 0.001 for SD and p < 0.001 for VD). The comparisons between consecutive follow-ups showed a statistically significant reduction in SD and VD at 1 and 3 days post-IVC. However, from day 3 onward, the SD and VD remained unchanged. There was no development or progression of tractional retinal detachment within the 7-day period after IVC. CONCLUSION OCTA-based quantification of the neovascularization on FVM in PDR is feasible, with high inter-reader agreement. The regression of neovascularization reaches a plateau 3 days after IVC. CLINICAL TRIAL REGISTRATION This trial is registered with the Chinese Clinical Trial Registry ( http://www.chictr.org.cn , registration number ChiCTR-IPR-17014160).
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ASYMMETRIC DIABETIC RETINOPATHY PROGRESSION IN PATIENTS WITH AXIAL ANISOMETROPIA.
Kim, DY, Song, JH, Kim, YJ, Lee, JY, Kim, JG, Yoon, YH, Joe, SG
Retina (Philadelphia, Pa.). 2018;(9):1809-1815
Abstract
PURPOSE To investigate the differences in the progression of diabetic retinopathy (DR) in both eyes of patients with axial anisometropia. METHODS A retrospective review was conducted on diabetic patients who had different axial lengths (difference greater than 1 mm) in each eye. The primary objective of this study was to analyze the differences in the progression of DR in both eyes of patients with axial anisometropia. Fundus images (fluorescein angiography and photographs of the fundus covering the Early Treatment Diabetic Retinopathy Study seven fields) were graded using the Early Treatment Diabetic Retinopathy Study DR grading system. Also, the severity of diabetic retinopathy was analyzed based on the axial length and subfoveal choroidal thickness. RESULTS Thirty-four of 6,963 patients with DR were included after applying the exclusion and inclusion criteria. The mean age was 53.53 ± 12.20 years and duration of diabetes was 9.63 ± 7.73 years. The mean axial length of the longer and shorter eye was 26.21 ± 2.04 mm and 23.21 ± 1.73 mm, respectively (P < 0.001). In shorter eyes, 61.7% (21 of 34) of the eyes had proliferative diabetic retinopathy. In contrast to the shorter eye, only 8 of the longer eyes (8 of 34, 23.5%) had proliferative diabetic retinopathy (McNemar test, P < 0.001). In eyes with thin subfoveal choroidal thickness (<250 µm), the proliferative diabetic retinopathy ratio was significantly lower (P = 0.007). CONCLUSION In patients with axial anisometropia, the longer eye had a lower degree of DR progression than the shorter eye. This result showed that elongation of the axial length had a protective effect against the progression of DR without individual confounding factors.
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A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial.
Liu, SL, Mahon, LW, Klar, NS, Schulz, DC, Gonder, JR, Hramiak, IM, Mahon, JL
BMJ open. 2017;(8):e015382
Abstract
INTRODUCTION Suboptimal screening for diabetic eye disease is a major cause of preventable vision loss. Screening barriers include mydriasis and the extra time patients need to attend dedicated eye screening appointments. In the Clearsight trial, we are testing whether screening by non-mydriatic ultra-wide field (NM UWF) imaging on the day patients attend their diabetes outpatient clinic visit improves detection of clinically important eye disease compared with usual screening. METHODS AND ANALYSIS Patients with diabetes due for a screening eye exam by the 2013 Canadian Diabetes Association (CDA) practice guidelines are being randomised to on-site screening by NM UWF imaging on the day of their clinic visit or to usual screening where, per CDA guidelines, they are encouraged to arrange an exam by an optometrist. The primary outcome is actionable eye disease (AED) based on a need for referral to ophthalmology and/or increased ocular surveillance. The primary analysis will use an intention-to-screen approach that compares the proportions of detected AED between on-site and usual screening groups under a superiority hypothesis in favour of on-site screening. With 740 randomised participants, the study will have 80% power to detect ≥5% absolute increase in the AED rate among on-site screening versus usual screening participants. This difference translates into a number-needed-to-screen by on-site screening of 20 to detect 1 additional person with AED. ETHICS AND DISSEMINATION The protocol was approved by the institutional review board of Western University. The findings of the trial will be disseminated directly to participants and through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER ClinicalTrials.Gov NCT02579837 (registered 16 October 2015). PROTOCOL ISSUE DATE 18 November 2015.
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Persistent Macular Thickening After Ranibizumab Treatment for Diabetic Macular Edema With Vision Impairment.
Bressler, SB, Ayala, AR, Bressler, NM, Melia, M, Qin, H, Ferris, FL, Flaxel, CJ, Friedman, SM, Glassman, AR, Jampol, LM, et al
JAMA ophthalmology. 2016;(3):278-85
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IMPORTANCE The prevalence of persistent diabetic macular edema (DME) after months of anti-vascular endothelial growth factor therapy and its effect on visual acuity are unknown. OBJECTIVE To assess subsequent outcomes of eyes with DME persisting for 24 weeks after initiating treatment with 0.5 mg of ranibizumab. DESIGN, SETTING, AND PARTICIPANTS We performed post hoc, exploratory analyses of a randomized clinical trial from March 20, 2007, through January 29, 2014, from 117 of 296 eyes (39.5%) randomly assigned to receive ranibizumab with persistent DME (central subfield thickness ≥250 μm on time domain optical coherence tomography) through the 24-week visit. INTERVENTIONS Four monthly intravitreous injections of ranibizumab and then as needed per protocol. MAIN OUTCOMES AND MEASURES Cumulative 3-year probabilities of chronic persistent DME (failure to achieve a central subfield thickness <250 μm and at least a 10% reduction from the 24-week visit on at least 2 consecutive study visits) determined by life-table analyses, and at least 10 letter (≥2 line) gain or loss of visual acuity among those eyes. RESULTS The probability of chronic persistent DME among eyes with persistent DME at the 24-week visit decreased from 100% at the 32-week visit to 81.1% (99% CI, 69.6%-88.6%), 55.8% (99% CI, 42.9%-66.9%), and 40.1% (99% CI, 27.4%-52.4%) at the 1-, 2-, and 3-year visits, respectively. At 3 years, visual acuity improved in eyes with and without chronic persistent DME through the follow-up period, respectively, by a mean of 7 letters and 13 letters from baseline. Among 40 eyes with chronic persistent edema through 3 years, 17 (42.5%) (99% CI, 23.1%-63.7%) gained 10 letters or more from baseline, whereas 5 (12.5%) (99% CI, 2.8%-31.5%) lost 10 letters or more from baseline. CONCLUSIONS AND RELEVANCE These data suggest less than half of eyes treated for DME with intravitreous ranibizumab have persistent central-involved DME through 24 weeks after initiating treatment. Among the 40% that then have chronic persistent central-involved DME through 3 years, longer-term visual acuity outcomes appear to be slightly worse than in the 60% in which DME does not persist. Nevertheless, when following the treatment protocol used in this trial among eyes with vision impairment from DME, long-term improvement in visual acuity from baseline is typical and substantial (≥2-line) loss of visual acuity is likely uncommon through 3 years, even when central-involved DME chronically persists.
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[Expected effect of retinal thickness after focal photocoagulation in diabetic macular oedema].
Garcia-Rubio, YZ, Razo Blanco-Hernández, DM, Lima-Gómez, V
Cirugia y cirujanos. 2016;(5):356-62
Abstract
BACKGROUND Macular oedema is a form of diabetic retinopathy that can be treated with photocoagulation. The expected effect of treatment varies, and may depend on the previous characteristics of retinal thickening. OBJECTIVE To determine whether the change in retinal thickness after focal photocoagulation for diabetic macular oedema varies due to the presence of anatomical features that may justify a separate assessment. MATERIAL AND METHODS Non-experimental, comparative, retrospective, longitudinal study. The mean percentage change in macular volume was compared in eyes with diabetic macular oedema, 3 weeks after focal photocoagulation. The analysis was stratified according to the presence of central and perifoveal temporal thickening (Mann-Whitney U). A regression analysis was performed to identify the contribution of the anatomical variables before photocoagulation to the change in macular volume. RESULTS A total of 72 eyes were evaluated. The mean change of macular volume in the sample was -0.68±3.84%. In the multiple regression analysis, the changes of perifoveal temporal (beta 0.54, p<0.001) and central field thickness (beta 0.3, p =0.01) contributed to the change of macular volume (R=0.64). Macular volume decreased by a mean of -2.1±4.3% in eyes with temporal perifoveal thickening, and increased by 0.5±2.8% (p =0.007) in eyes with no thickening. CONCLUSION Perifoveal temporal thickening before photocoagulation changes the expected effect of this therapy on macular volume in eyes with focal diabetic macular oedema. It is recommended to evaluate the effect separately, and according to the perifoveal temporal thickness.
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Clinical efficacy of navigated panretinal photocoagulation in proliferative diabetic retinopathy.
Chhablani, J, Sambhana, S, Mathai, A, Gupta, V, Arevalo, JF, Kozak, I
American journal of ophthalmology. 2015;(5):884-9
Abstract
PURPOSE To compare the clinical efficacy of navigated pattern and conventional slit-lamp pattern panretinal photocoagulation (PRP). DESIGN Randomized clinical trial. METHODS Seventy-four eyes with proliferative diabetic retinopathy (PDR) in need of PRP were randomly assigned to 1 of 4 groups: PRP conventional pattern 30 ms, 100 ms, navigated pattern 30 ms, 100 ms pulse. Navigated laser is a fundus camera-based photocoagulator with retinal eye tracking. Outcome variables included stability of visual acuity, regression or development of neovascularization and need for retreatment sessions and surgical intervention, pain perception, and procedure time. RESULTS There was no change in visual acuity between pre- and post-treatment measurements among the study groups. Short pulse groups in total required 22 procedures compared to 12 procedures in long pulse groups (P < .05). A trend toward worse outcome using 30 ms pulse duration treatments is expressed by slightly increased relative risk of 1.3 compared to 100 ms groups. Only 2 eyes required vitreoretinal surgery for nonclearing vitreous hemorrhage, 1 in each 30 ms group; insignificantly different between study groups (P = .98). The pain score was lower with navigated laser as compared to conventional laser in both 30 ms groups (P = .1) and 100 ms groups, where it reached statistical significance (P = .02). Pain experience was significant (P < .001) between navigated 100 ms pattern and conventional single-spot 100 ms treatments. CONCLUSIONS This study demonstrates better clinical efficacy of 100 ms compared to 30 ms treatments using both conventional and navigated pattern lasers. The ability to use long-pulse-duration navigated pattern treatments broadens therapeutic options for PRP in proliferative diabetic retinopathy.