Diabetic Retinopathy Study Visual Acuity Research Articles

Health Utility Values Among Patients With Diabetic Retinopathy, Wet Age-Related Macular Degeneration, and Cataract in Thailand: A Multicenter Survey Using Time Trade-Off, EQ-5D-5L, and Health Utility Index 3

ObjectivesThis study aimed to establish normative health utility data in Thai patients with diabetic retinopathy, wet age-related macular degeneration, and cataract; evaluate the sensitivity of different utility instruments to visual impairment; explore the relationship among these health utility values with the vision-specific quality of life (QoL); and assess the association of baseline characteristics and visual acuity level with health utility values and vision-specific QoL. MethodsThis multicenter cross-sectional survey included 309 patients from tertiary eye centers. We used health utility instruments (time trade-off [TTO], EuroQol five-dimension [EQ-5D-5L], and Health Utility Index 3 [HUI3]) and vision-specific QoL instrument (National Eye Institute Visual Function Questionnaire) for face-to-face interviews. Demographic data and Early Treatment Diabetic Retinopathy Study visual acuity were recorded during the participants ophthalmic visits. Univariable and multivariable mixed-effect models were used to evaluate factors associated with the utility scores. Health utility scores among each type of eye disease were compared. ResultsThe overall mean utility values from the TTO, EQ-5D-5L, and HUI3 were 0.84 ± 0.25, 0.70 ± 0.19, and 0.68 ± 0.26, respectively. The health utility scores obtained from TTO and HUI3 showed a significant response to severe visual impairment or worse. Health utility scores from HUI3 (r = 0.54; P < .01) and EQ-5D-5L (r = 0.43; P < .01) displayed a moderate correlation with the National Eye Institute Visual Function Questionnaire score. There were no significant differences in health utility value among the 3 diseases upon adjusting for the visual acuity level and demographics. ConclusionsVisual acuity level has a greater impact on a patient’s QoL than the type of eye disease. HUI3 and EQ-5D-5L and TTO are suitable for measuring health utility in leading causes of blindness.

Stereotactic radiotherapy for neovascular age-related macular degeneration (STAR): a pivotal, randomised, double-masked, sham-controlled device trial

Neovascular age-related macular degeneration (nAMD) is a leading cause of blindness. The first-line therapy is anti-vascular endothelial growth factor (anti-VEGF) agents delivered by intravitreal injection. Ionising radiation mitigates key pathogenic processes underlying nAMD, and therefore has therapeutic potential. STAR aimed to assess whether stereotactic radiotherapy (SRT) reduces the number of anti-VEGF injections required, without sacrificing visual acuity. This pivotal, randomised, double-masked, sham-controlled trial enrolled participants with pretreated chronic active nAMD from 30 UK hospitals. Participants were randomly allocated in a 2:1 ratio to 16-Gray (Gy) SRT delivered using a robotically controlled device or sham SRT, stratified by treatment centre. Eligible participants were aged 50 years or older and had chronic active nAMD, with at least three previous anti-VEGF injections, including at least one in the last 4 months. Participants and all trial and image reading centre staff were masked to treatment allocation, except one unmasked statistician. The primary outcome was the number of intravitreal ranibizumab injections required over 2 years, tested for superiority (fewer injections). The main secondary outcome was Early Treatment Diabetic Retinopathy Study visual acuity at two years, tested for non-inferiority (five-letter margin). The primary analysis used the intention-to-treat principle, and safety was analysed per-protocol on participants with available data. The study is registered with ClinicalTrials.gov (NCT02243878) and is closed for recruitment. 411 participants enrolled between Jan 1, 2015, and Dec 27, 2019, and 274 were randomly allocated to the 16-Gy SRT group and 137 to the sham SRT group. 240 (58%) of all participants were female, and 171 (42%) of all participants were male. 241 participants in the 16-Gy SRT group and 118 participants in the sham group were included in the final analysis, and 409 patients were treated and formed the safety population, of whom two patients allocated to sham treatment erroneously received 16-Gy SRT. The SRT group received a mean of 10·7 injections (SD 6·3) over 2 years versus 13·3 injections (5·8) with sham, a reduction of 2·9 injections after adjusting for treatment centre (95% CI -4·2 to -1·6, p<0·0001). The SRT group best-corrected visual acuity change was non-inferior to sham (adjusted mean letter loss difference between groups, -1·7 letters [95% CI -4·2 to 0·8]). Adverse event rates were similar across groups, but reading centre-detected microvascular abnormalities occurred in 77 SRT-treated eyes (35%) and 13 (12%) sham-treated eyes. Overall, eyes with microvascular abnormalities tended to have better best-corrected visual acuity than those without. Fewer ranibizumab injections offset the cost of SRT, saving a mean of £565 per participant (95% CI -332 to 1483). SRT can reduce ranibizumab treatment burden without compromising vision. Medical Research Council and National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme.

Efficacy and safety of transdermal electrical stimulation in patients with nonarteritic anterior ischemic optic neuropathy

BackgroundNo effective treatment for NAION with strong evidence has been established till date. The aim of this investigator-led, prospective, non-randomized, open-label, uncontrolled multi-center exploratory clinical trial is to evaluate the efficacy and safety of transdermal electrical stimulation (TdES) using skin electrodes in patients with NAION.MethodsFive patients with monocular NAION underwent TdES (10-ms biphasic pulses, 1.0 mA, 20 Hz, 30 min) of the affected eye six times at 2-week intervals. The primary endpoint was the logarithm of the mini-mum angle of resolution (logMAR) visual acuity at 12 weeks compared with 0 weeks. The secondary endpoints were changes in the best-corrected logMAR visual acuity, Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity, and mean deviation (MD) of the Humphrey field analyzer (HFA) 10–2 and HFA Esterman test scores. Additionally, the safety of TdES was evaluated.ResultsLogMAR visual acuity improved by ≥ 0.1 in two eyes, and ETDRS visual acu-ity improved by ≥ 5 characters in one eye. The mean change in logMAR visual acuity from week 0 showed an increasing trend. The mean MD of HFA 10–2 showed no obvious change, while HFA Esterman score improved in four eyes. All patients completed the study according to the protocol, and no treatment-related adverse events were observed.ConclusionsTdES treatment may have improved visual acuity and visual field in some patients. Further sham-controlled study in larger cohort is needed on its effectiveness.Trial registrationUMIN, UMIN000036220. Registered 15 March, 2019, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041261.

Analysis of the improvement in monocular amblyopia visual acuity caused by the changes in non-amblyopia visual acuity in 74 adults.

To observe the clinical phenomenon of amblyopia vision improvement in patients with monocular amblyopia over 18 years old after non-amblyopia diseases, analyze the conditions and causes of vision improvement, explore the plasticity of the adult optic nerve, and provide a clinical basis for the treatment of adult amblyopia. A total of 74 patients with monocular amblyopia combined with non-amblyopia visual acuity decline from 2018 to 2021 were collected. The patient's age, initial best-corrected visual acuity (BCVA), pattern visual evoked potential examination results, and visual acuity regression were recorded. The BCVA of amblyopia was recorded every 3 months using an early treatment of diabetic retinopathy study visual acuity chart. In the 3rd month, BCVA increased by 16.2%, reaching 98% in the 9th month and 100% in the 12th months. According to the age of patients, the group aged 18 to 35 years was better than the group aged 35 to 60 years, whereas the group aged 35 to 60 years was better than the group aged over 60 years (P < .05). According to the comparison of initial visual acuity, the BCVA of the < 5 letter group was lower than that of the other 2 groups (P < .05). According to the pattern visual evoked potential results, the peak time of the < 10 ms group was better than that of the 10 to 20 ms group; the 10 to 20 ms group was better than that of the > 20 ms group; the peak decrease of the < 30% group was better than that of the 30% to 50% group; and the 30% to 50% group was better than that of the > 50% group (P < .05). The visual acuity regression of amblyopia in the 0.5 to 1-year group was higher than that in the other 2 groups (P < .05). This study confirms that adult amblyopia can still be cured under certain conditions. This visual plasticity is related to age, initial visual acuity, and excitability of the visual center. This study provides new clinical evidence and diagnostic ideas for the study of the pathogenesis of adult amblyopia.

Visit Adherence and Visual Acuity in Study of COmparative Treatments for REtinal Vein Occlusion 2 (SCORE2)

ABSTRACT Purpose We quantify the association between visit adherence and visual acuity (VA) in retinal vein occlusions (CRVO). Methods The SCORE2 protocol included a visit every 4 weeks (every 28–35 days) during the first year. Visit adherence was measured as follows: number of missed visits, average and longest (avg and max days) visit interval, and average and longest (avg and max missed days) and unintended visit interval. Avg and max missed days were categorized as on time (0 days), late (>0–60 days), and very late (>60 days). The primary outcome was a change in the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score (VALS) between baseline study visit and last attended visit during Year 1, using multivariate linear regression models controlling for numerous demographic and clinical factors. Results After adjustment, for each visit missed, patients lost 3.0 letters (95% CI: −6.2, 0.2) of vision (p = .07). On average, the 48 patients who missed at least 1 visit lost 9.4 letters (95% CI: −14.4, −4.3, p < .001) of vision after adjustment. Average days and maximal intervals between visits were not associated with changes in VALS (p > .22) for both comparisons. However, when a visit was missed, the average missed days between missed visits and the max missed interval were both associated with loss of VALS (both variables: 0 days missed as reference, late [1–60 days] −10.8 letters [95% CI: −16.9, −4.7], very late [>60 days] −7.3 letters [95% CI: −14.5, −0.2]; p = .003 for both). Conclusions Visit adherence is associated with VALS outcomes in CRVO patients.

Comparison of Retinal Nerve Fiber Layer Thickness in Diabetic Patients with and without Diabetic Retinopathy and Healthy Individuals using Ocular Coherence Tomography

Objectives: Using Ocular Coherence Tomography, the study aimed to examine the RNFL thickness of type diabetics, patients with Diabetic Retinopathy, and healthy persons. Methods: 101 patients from the outside patient department and the Retina department of Tertiary Eye Care Hospital participated in this research. The cross-sectional study design was used. Non-probability consecutive sampling was utilized as the sampling technique. Patients were selected according to inclusion criteria. Visual Acuity was assessed using an (ETDRS) Early Treatment Diabetic Retinopathy Study Visual acuity chart at a distance of 6m. After the Ophthalmological Examination was done by a doctor, Ocular Coherence Tomography (Heidelberg Spectralis) was performed to assess RNFL thickness. The association between different types of diabetic retinopathy, Type-2 Diabetes, Normal Healthy, and retinal RNFL thickness was determined using a one-way ANOVA test. Results: The age range of the participants was between 40 and 69 years, with a mean of 55.68 ±10.437 years. 15.3% had diabetes for 1 to 5 years. 24% had Diabetes for 6 to 10 yea 19.9% had a Diabetes duration of 19.9%. The RNFL thickness was significantly decreased in type 2 diabetics, NPDR, and PDR as compared to normal Healthy individuals (p&lt;.001). Age and duration of diabetes were closely correlated with the retinal nerve fiber layer (p&lt;0.001). Conclusion: This study indicated that the (retinal nerve fiber layer) RNFL was considerably thinner in all quadrants of diabetic retinopathy (NPDR, PDR), type 2 diabetics, and healthy persons. Age and duration of diabetes were significantly correlated with average RNFL thickness.

Evaluating the efficacy and safety of transdermal electrical stimulation on the visual functions of patients with retinitis pigmentosa: a clinical trial protocol for a prospective, multicentre, randomised, double-masked and sham-controlled design (ePICO trial)

IntroductionPreviously, we conducted a clinical trial to evaluate the safety and efficacy of transdermal electrical stimulation (TdES) with skin electrodes to improve the visual functions in patients with retinitis pigmentosa...

Longitudinal Assessment of Ellipsoid Zone Recovery Using En Face Optical Coherence Tomography After Retinal Detachment Repair

Suboptimal functional outcomes after rhegmatogenous retinal detachment (RRD) repair may be related to photoreceptor abnormalities, including alterations of the ellipsoid zone (EZ) that may not be apparent on cross-sectional optical coherence tomography (OCT). This study assessed EZ recovery using en face OCT after RRD repair and its association with visual acuity. Post hoc analysis of a randomized controlled trial. Patients with macula-off RRD were monitored at 3, 6, 12, and 24 months postoperatively and annually thereafter. En face OCT of the EZ slab were analyzed. Hyporeflective areas were colocalized with EZ abnormalities on cross-sectional OCT B-scans and measured by 2 masked graders. Primary outcome was change in area of EZ hyporeflectivity from 3 to 24 months, and its association with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity recovery was also assessed. In total, 271 images of 61 patients were assessed. Mean area of hyporeflectivity significantly decreased from 3 to 24 months (-2.98 mm2; 95% CI, 1.82-4.13 mm2; P < .0001), with further reductions up to 4 years. Linear regression revealed an association between change in hyporeflective area and change in the ETDRS letter score from 3 to 24 months (β=-0.31, P=.009, R2=14.8%) and between duration of macula-off and change in hyporeflective area from 3 to 24 months (β=-0.37, P=.018, R2=13.7%). En face OCT provides a novel biomarker for visualizing and quantifying EZ recovery after RRD repair that is associated with ETDRS visual acuity recovery. A steady decline in the area of EZ hyporeflectivity was observed over many years with delayed recovery in patients with longer duration of macula-off.

Correlation of macular sensitivity measures and visual acuity to vision-related quality of life in patients with age-related macular degeneration

BackgroundVisual acuity is commonly used as a functional outcome measure in patients with age-related macular degeneration (AMD), despite having a weak correlation with self-perceived visual quality of life. Microperimetry is a useful method of detecting loss of macular function. We wanted to investigate the relationship between these two objective visual outcome measures and subjective vision-related quality of life, finding out which objective measure is more patient-relevant.MethodsFifty-one consecutive patients with AMD were recruited to the study. Participants were required to complete the Visual Function Questionnaire 39, the Early Treatment Diabetic Retinopathy Study visual acuity examination and a microperimetry assessment using the Micro Perimeter 3. One patient withdrew consent and seven patients dropped out due to cooperation difficulties under microperimetry. Forty-three patients with AMD were included in the study: twenty-eight patients with late AMD (exudative AMD) and fifteen patients with early (non-exudative) AMD. The right eye was included as standard, as was the eye with the best-corrected visual acuity.ResultsThere was a higher correlation between vision-related quality of life and macular sensitivity (r = 0.458; p = 0.014) than between vision-related quality of life and visual acuity (r = 0.446; p = 0.018) in patients with late AMD. There was a positive correlation between vision-related quality of life and macular sensitivity in patients with early AMD (r = 0.542; p = 0.037) while the correlation between vision-related quality of life and visual acuity in these patients was not statistically significant. Composite score (r = 0.469; p = 0.012) correlated highest with the nasal outer macular sub-region and near-distance activities score (r = 0.652; p < 0.001) correlated highest with the nasal inner macular sub-region in patients with late AMD. Correlations between composite score and macular sub-regions in patients with early AMD were not significant, but near-distance activities score correlated with the nasal outer macular sub-region in these patients (r = 0.469; p = 0.012).ConclusionsMacular sensitivity as measured using microperimetry correlates with vision-related quality of life in early AMD and in late AMD, showing it to be a patient-relevant outcome measure. Furthermore, the nasal sub-regions of the macula appear to be preferred retinal loci in patients with AMD.(338 words)

Optic Disc Pit Maculopathy: One-Year Outcomes of Pars Plana Vitrectomy with Foveal Sparing Inverted Internal Limiting Membrane Flap.

PurposeTo evaluate the anatomical and visual outcomes in optic disc pit maculopathy following pars plana vitrectomy (PPV) with inverted internal limiting membrane (ILM) flapMethodsRetrospective interventional case series of 10 patients diagnosed with serous macular detachment secondary to optic disc pit who underwent PPV with inverted ILM flap and were followed up for a year.ResultsA p-value of less than 0.05 was defined as statistically significant. The mean age of patients was 27.2 ± 10.6 years, preoperatively the mean best-corrected visual acuity of the logarithm of the minimum angle of resolution was 0.91 ± 0.42 (approximate Snellen equivalent 20/162), which improved to the logarithm of the minimum angle of resolution of 0.58 ± 0.29 (approximate Snellen equivalent 20/76) at end of one year, (p=0.008). The mean central macular thickness was 804.9 ± 294.1 m which improved to 273.4 ± 102.54 m, (p=0.002). After surgery, at end of one year, 60% of patients (6/10) had 15- or more-than-15-letter improvement of vision on Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing, 20% (2/10) gained a 10-letter improvement and 20% (2/10) retained the same vision.ConclusionPPV with inverted ILM flap can be considered as a good approach for the management of serous macular detachment secondary to optic disc pit and produce good anatomical and visual results at one year with stabilization of the disease.

Shortening the Early Treatment Diabetic Retinopathy Study visual acuity test utilizing a novel computer software: reproducibility in control and patient eyes.

To describe and compare a method of computerized visual acuity (VA) testing software to the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Setting: Single tertiary institution. Prospective study including right eyes of volunteers (N = 109) and patients (N = 126). Subjects were tested in a random order twice with the ETDRS chart and twice with the VA software. For ETDRS, we calculated the final VA separately for each run, using four different test termination criteria (1-miss in a row, 2-miss in a row, 50% miss and per-letter). For software testing, we calculated final VA with a variety of number of letters presented. The main outcome measures were reproducibility and number of letters required to exceed ETDRS reproducibility. For ETDRS, the average number of letters presented was 55.1 ± 9, 54.3 ± 10, 53.1 ± 10 and 70 for the 1-miss, 2-miss, 50% termination and per-letter criterion. The test-retest variability (TRV) of ETDRS was 0.29, 0.42, 0.17 and 0.141 for the 1-miss in a row, 2-miss in a row, 50% and per-letter termination criteria. For the software VA test, TRV was 0.202, 0.138 and 0.112 after presenting 6, 11 and 20 letters. The reproducibility of the software was equal to the ETDRS at 11 letters and thereafter surpassed. Similar results were achieved in the patient group. This study demonstrates that by utilizing a VA testing software, based on advanced threshold testing algorithms we were able to duplicate, and surpass, the reproducibility of the ETDRS chart while presenting much fewer letters.

Psychophysical Validation of a Novel Active Learning Approach for Measuring the Visual Acuity Behavioral Function.

PurposeTo evaluate the performance of the quantitative visual acuity (qVA) method in measuring the visual acuity (VA) behavioral function.MethodsWe evaluated qVA performance in terms of the accuracy, precision, and efficiency of the estimated VA threshold and range in Monte Carlo simulations and a psychophysical experiment. We also compared the estimated VA threshold from the qVA method with that from the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) and Freiburg Visual Acuity Text (FrACT) methods. Four repeated measures with all three methods were conducted in four Bangerter foil conditions in 14 eyes.ResultsIn both simulations and psychophysical experiment, the qVA method quantified the full acuity behavioral function with two psychometric parameters (VA threshold and VA range) with virtually no bias and with high precision and efficiency. There was a significant correlation between qVA estimates of VA threshold and range in the psychophysical experiment. In addition, qVA threshold estimates were highly correlated with those from the E-ETDRS and FrACT methods.ConclusionsThe qVA method can provide an accurate, precise, and efficient assessment of the full acuity behavioral function with both VA threshold and range.Translational RelevanceThe qVA method can accurately, precisely, and efficiently assess the full VA behavioral function. Further research will evaluate the potential value of these rich measures for both clinical research and patient care.

Characterization of Retinal Microvascular and Choroidal Structural Changes in Parkinson Disease

Noninvasive retinal imaging may detect structural changes associated with Parkinson disease (PD) and may represent a novel biomarker for disease detection. To characterize alterations in the structure and microvasculature of the retina and choroid in eyes of individuals with PD and compare them with eyes of age- and sex-matched cognitively healthy control individuals using optical coherence tomography (OCT) and OCT angiography (OCTA). This cross-sectional study was conducted at the Duke Neurological Disorders Clinic in Durham, North Carolina. Individuals aged 50 years or older with a diagnosis of PD were eligible for inclusion and underwent an evaluation and diagnosis confirmation before enrollment. Control individuals aged 50 years or older and without subjective cognitive dysfunction, a history of tremor, or evidence of motor dysfunction consistent with parkinsonism were solicited from the clinic or the Duke Alzheimer's Disease Prevention Registry. Individuals with diabetes, glaucoma, retinal pathology, other dementias, and corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity worse than 20/40 Snellen were excluded. Data were analyzed between January 1, 2020, and March 30, 2020. All participants underwent OCT and OCTA imaging. Generalized estimating equation analysis was used to characterize the association between imaging parameters and PD diagnosis. Superficial capillary plexus vessel density (VD) and perfusion density (PFD) were assessed within the ETDRS 6 × 6-mm circle, 6 × 6-mm inner ring, and 6 × 6-mm outer ring, as was the foveal avascular zone area. Peripapillary retinal nerve fiber layer thickness, macular ganglion cell-inner plexiform layer thickness, central subfield thickness, subfoveal choroidal thickness, total choroidal area, luminal area, and choroidal vascularity index (CVI) were measured. A total of 124 eyes of 69 participants with PD (39 men [56.5%]; mean [SD] age, 71.7 [7.0] years) and 248 eyes of 137 control participants (77 men [56.2%]; mean [SD] age, 70.9 [6.7] years) were analyzed. In the 6 × 6-mm ETDRS circle, VD (β coefficient = 0.37; 95% CI, 0.04-0.71; P = .03) and PFD (β coefficient = 0.009; 95% CI, 0.0003-0.018; P = .04) were lower in eyes of participants with PD. In the inner ring of the 6 × 6-mm ETDRS circle, VD (β coefficient = 0.61; 95% CI, 0.20-1.02; P = .003) and PFD (β coefficient = 0.015; 95% CI, 0.005-0.026; P = .004) were lower in eyes of participants with PD. Total choroidal area (β coefficient = -1.74 units2; 95% CI, -3.12 to -0.37 units2; P = .01) and luminal area (β coefficient = -1.02 units2; 95% CI, -1.86 to -0.18 units2; P = .02) were greater, but CVI was lower (β coefficient = 0.5%; 95% CI, 0.2%-0.8%; P < .001) in eyes of individuals with PD. This study found that individuals with PD had decreased retinal VD and PFD as well as choroidal structural changes compared with age- and sex-matched control participants. Given the observed population differences in these noninvasive retinal biomarkers, further research into their clinical utility in PD is needed.

Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.

Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.

MULTIFOCAL ELECTRORETINOGRAPHY AND SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY IN MACULA-OFF RHEGMATOGENOUS RETINAL DETACHMENT: A Prospective Cohort Study.

To analyze the temporal trends in structural changes using spectral-domain optical coherence tomography and functional changes using multifocal electroretinogram after rhegmatogenous retinal detachment surgery. This prospective cohort study enrolled 69 patients with macula-off rhegmatogenous retinal detachment who underwent successful surgery. Early Treatment Diabetic Retinopathy Study visual acuity, multifocal electroretinogram evaluation of the central 5°, and spectral-domain optical coherence tomography were recorded at 1, 3, 6, and 12 months (M) after surgery. The fellow eye served as the control group for multifocal electroretinogram parameters. Between M1 and M12, visual acuity improved from 64 to 75 letters (P = 0.001) and implicit time of N1 decreased from 27.8 to 25.2 milliseconds (P = 0.001), whereas the other parameters did not vary significantly. Amplitude and implicit time values did not reach normal values at M12. Alterations of the ellipsoid zone and the external limiting membrane decreased over time (P = 0.001). P1 implicit time correlated independently with the alteration of the external limiting membrane (P = 0.007). Foveal wave amplitudes remain lower than normal values after successful surgery of rhegmatogenous retinal detachment, whereas anatomical improvement was found for outer retinal abnormalities and subretinal edema fluid. Retinal recovery improves N1 implicit time over time. Disruption of external limiting membrane seems to be predictive of increased P1 implicit time.

Effect of Face-Down Positioning vs Support-the-Break Positioning After Macula-Involving Retinal Detachment Repair

A lack of consensus exists with regard to the optimal positioning regimen for patients after macula-involving retinal detachment (RD) repair. To evaluate the effect of face-down positioning vs support-the-break positioning on retinal displacement and distortion after macula-involving RD repair. A prospective 6-month single-masked randomized clinical trial was conducted at a multicenter tertiary referral setting from May 16, 2016, to May 1, 2018. Inclusion criteria were fovea-involving rhegmatogenous RD; central visual loss within 14 days; patients undergoing primary vitrectomy and gas surgery, under local anesthetic; patients able to give written informed consent; and 18 years old and older. Analysis was conducted following a modified intention-to-treat principle, with patients experiencing a redetachment or failure to attach the macula being excluded from analysis. Participants were randomized 1:1 to receive face-down positioning or support-the-break positioning for a 24-hour period postoperatively. Positioning compliance was not monitored. The proportion of patients with retinal displacement on autofluorescence imaging at 6 months postoperatively. Secondary outcomes included proportion of patients with displacement at 2 months; amplitude of displacement at 2 and 6 months; corrected Early Treatment Diabetic Retinopathy Study visual acuity; objective Distortion Scores; and quality of life questionnaire scores at 6 months. Of the 262 randomized patients, 239 were analyzed (171 male [71.5%]; mean [SD] age, 60.8 [9.8] years). At 6 months, retinal displacement was detected in 42 of 100 (42%) in the face-down positioning group vs 58 of 103 (56%) in the support-the-break positioning group (odds ratio, 1.77; 95%CI, 1.01-3.11; P = .04). The degree of displacement was lower in the face-down group. Groups were similar in corrected visual acuity (face-down, 74 letters vs support-the-break, 75 letters), objective D Chart Distortion Scores (range: 0, no distortion to 41.6, severe distortion; with face-down at 4.5 vs support-the-break at 4.2), and quality of life scores (face-down 89.3 vs support-the-break 89.0) at 2 and 6 months. Retinal redetachment rate was similar in both groups (face-down group, 12.2% and support-the-break group, 13.7%). Retinal folds were less common in the face-down positioning group vs the support-the-break positioning group (5.3% vs 13.5%, respectively; odds ratio, 2.8; 95% CI, 1.2-7.4; P = .03). Binocular diplopia was more common in the support-the-break group compared with the face-down positioning group (7.6% vs 1.5%, respectively; odds ratio, 5.3; 95% CI, 1.3-24.6; P = .03). Amplitude of displacement was associated with worse visual acuity (r = -0.5; P < .001) and distortion (r = 0.28; P = .008). In this study, findings suggest that face-down positioning was associated with a reduction in the rate and amplitude of postoperative retinal displacement after macula-involving RD repair and with a reduction in binocular diplopia. No association was found with visual acuity or postoperative distortion. ClinicalTrials.gov Identifier: NCT02748538.

Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy

PurposeTo compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).MethodsProspective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% threshold tested. Patients in the TCL group were treated with 577 nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.ResultsEighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23 ± 8.59 and 6.61 ± 6.35 letters, respectively, (SML–TCL difference: −0.38 letters; 95% confidence interval (CI):−3.58–2.81; Pnon-inferiority = 0.0026). There was no statistically significant difference between the two groups (t = 0.240, P = 0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (χ2 = 3.67, P = 0.056).ConclusionsBoth SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.

Effects of Flavanol-Rich Dark Chocolate on Visual Function and Retinal Perfusion Measured With Optical Coherence Tomography Angiography

A recently reported randomized clinical trial suggested beneficial effects of vasodilating flavanols in dark chocolate on visual function without objective quantification of retinal perfusion. To assess the effects of dark chocolate flavanols on subjective visual function and retinal perfusion objectively quantified on optical coherence tomography (OCT) angiography. This randomized, masked double-blind crossover clinical trial analyzed 22 healthy participants at the Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany, in July 2018. Analysis was intention to treat. Analysis began in July 2018. Participants were randomized to consume 20 g of dark chocolate containing 400 mg of flavanols or 7.5 g of milk chocolate. Two hours later, visual function and retinal perfusion on OCT angiography were evaluated. Systemic blood pressure was measured to rule out artifacts on OCT angiography. The primary end point was macular retinal perfusion quantified as vessel density on OCT angiography. The secondary end point was subjective visual function (Early Treatment Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, and Mars chart contrast sensitivity). All 22 participants (13 women [59.1%]; mean [SD] age, 27.3 [11.1] years) completed the trial. No relevant differences in baseline parameters between groups were identified. No change in the primary outcome measure, retinal perfusion, could be detected after consumption of dark vs milk chocolate (superficial plexus 48.0% vs 47.5%, treatment effect: -0.59 [95% CI, -2.68 to 1.50], P = .56; deep plexus 54.1% vs 54.0%, treatment effect: -1.14 [95% CI, -4.01 to 1.73], P = .42). No differences in changes in the secondary outcome parameters Early Treatment Diabetic Retinopathy Study visual acuity, Pelli-Robson chart, or Mars chart contrast sensitivity could be detected. Potentially confounding effects of changes in blood pressure were excluded. In contrast to a previous similarly sized randomized clinical trial reporting beneficial effects on visual function, no short-term effects of flavanol-rich dark chocolate on automatically assessed retinal blood flow on OCT angiography or subjective visual function were observed in this study. As this small trial does not rule out the possibility of benefits, further trials with larger sample sizes would be needed to rule in or out possible long-term benefits confidently. German Clinical Trials Register identifier: DRKS00015065.

Clinical Trial to Evaluate Safety and Efficacy of Transdermal Electrical Stimulation on Visual Functions of Patients with Retinitis Pigmentosa

To evaluate the safety and efficacy of transdermal electrical stimulation (TdES) with skin electrodes on improving the visual functions of patients with retinitis pigmentosa (RP), twenty eyes of 10 patients with RP underwent TdES (10-ms biphasic pulses, 20 Hz, 30 min) 6 times at 2 week intervals. All patients were stimulated bilaterally with 1.0 mA pulses. The primary endpoint was safety, and the secondary endpoints were the changes in the best-corrected visual acuity (BCVA), visual fields determined by the Humphrey field analyzer (HFA) 10-2 and Goldmann perimetry, and answers to the Visual Function Questionnaire-25. All of the 10 enrolled patients completed the study according to the protocol. No adverse events related to the treatments were reported during the follow-up examinations. The mean BCVA and Early Treatment Diabetic Retinopathy Study visual acuity were significantly improved after the TdES (P = 0.0078 and P = 0.001, respectively). The mean deviation of the HFA 10-2 was also significantly improved (P = 0.0076). We conclude that TdES with skin electrode is a safe therapeutic option and should be considered as a treatment option for patients with RP.

The effect of single dose adjunctive dexamethasone implant on diabetic macular edema in patients on anti-vascular endothelial growth factor treatment: 1 year follow-up from a real-life practice

To evaluate the effect of single-dose intravitreal dexamethasone (Dx) implant as an adjunctive treatment for patients undergoing anti-vascular endothelial growth factor (anti-VEGF) treatment with poor response. Eighty-four eyes of 72 patients with non-proliferative diabetic retinopathy and diabetic macular edema with a poor response to 3 loading doses of intravitreal ranibizumab (IVR) were included in this study. Group 1 consisted of forty-four eyes which went on a Pro re Nata (PRN) dose regimen of IVR injections after 3 loading doses of ranibizumab, and Group 2 consisted of 40 eyes which received a single dose Dx implant as the 4th injection after 3 loading doses of ranibizumab injections and then went on PRN IVR injections. Patients whose macular edema was unchanged or decreased by<25% and gained three letters or less on the Early Treatment Diabetic Retinopathy Study visual acuity (VA) chart were defined as poorly responsive. Follow-up time was 12 months. After the 12-month follow-up, Group 1 gained a median of five letters, and Group 2 gained a median of three letters. After the fourth injection, both groups had statistically significant VA gains at 4, 6, 7, and 12 months when compared with controls (P<.05). Group 2 had a significantly increased VA at 4 and 6 months when compared with controls. However, beginning at 7 months, Group 1 had significantly increased VA when compared with Group 2. At both 4 and 6 months, controls (first 3 months after Dx implantation) in Group 2 had significantly decreased central macular thickness (CMT) when compared with Group 1. However, after 7 months, there was no significant difference between groups with regard to CMT (P>.05). A single-dose Dx implant after three consecutive IVR injections for poorly responsive diabetic macular edema has limited effect on either VA or CMT. The need for IVR injections did not decrease with a Dx implant.