Safety and acceptability of an organic light-emitting diode sleep mask as a potential therapy for retinal disease.

PurposeThe purpose of the study was to study the effect of an organic light-emitting diode sleep mask on daytime alertness, wellbeing, and retinal structure/function in healthy volunteers and in diabetic macular oedema (DMO).Patients and methodsHealthy volunteers in two groups, 18-30 yrs (A), 50-70 yrs (B) and people with DMO (C) wore masks (504 nm wavelength; 80 cd/m2 luminance; ≤8 h) nightly for 3 months followed by a 1-month recovery period. Changes from baseline were measured for (means): psychomotor vigilance task (PVT) (number of lapses (NL), response time (RT)), sleep, depression, psychological wellbeing (PW), visual acuity, contrast sensitivity, colour, electrophysiology, microperimetry, and retinal thickness on OCT.ResultsOf 60 participants, 16 (27%) withdrew, 8 (13%) before month 1, due to sleep disturbances and mask intolerance. About 36/55 (65%) who continued beyond month 1 reported ≥1 adverse event. At month 3 mean PVT worsened in Group A (RT (7.65%, P<0.001), NL (43.3%, P=0.005)) and mean PW worsened in all groups (A 28.0%, P=0.01, B 21.2%, P=0.03, C 12.8%, P<0.05). No other clinically significant safety signal was detected. Cysts reduced/resolved in the OCT subfield of maximal pathology in 67% Group C eyes. Thinning was greater at 3 and 4 months for greater baseline thickness (central subfield P<0.001, maximal P<0.05).ConclusionSleep masks showed no major safety signal apart from a small impairment of daytime alertness and a moderate effect on wellbeing. Masks were acceptable apart from in some healthy participants. Preliminary data suggest a beneficial effect on retinal thickness in DMO. This novel therapeutic approach is ready for large clinical trials.

Near-infrared reflectance and autofluorescence imaging characteristics of choroidal nevi.

PurposeTo report near-infrared reflectance (NIR-R), near-infrared autofluorescence (NIR-AF) and blue wave autofluorescence (BW-AF) appearance of choroidal nevi using a confocal scanning laser ophthalmoscope (cSLO).Patients and methodsNIR-R, NIR-AF and BW-AF images of choroidal nevi were compared with color fundus photos (CF). Images were graded as hyperreflective if reflectance was much greater than background, hyporeflective if less than background, and isoreflective if the same as the background.ResultsForty-two nevi of 39 patients were imaged. When compared with CF, nevi could be identified on 95% (40/42) NIR-R images (95% CI: 83.5-99.3). On NIR-R 71% (30/42) demonstrated hyperreflectance and 24% (10/42) were hyporeflective. Hyperreflectivity was demonstrated in 96% (23/24) of NIR-AF images (95% CI: 79.1-99.9) and 34% (14/41) of BW-AF images (95% CI: 20.0-50.5). On NIR-R, 29/40 (73%) were apparently smaller in comparison with CF and 11/40 (28%) had the same area. A correlation was found between NIR-R and NIR-AF (P=0.02) but not with BW-AF (P=0.15).ConclusionsNevi can be visualized well using NIR-R and NIR-AF imaging modalities, but are less frequently visible using BW-AF. These changes may be related to melanin within the choroid or chronic changes of the overlying retinal pigment epithelium.

Effectiveness of ranibizumab for neovascular age-related macular degeneration using clinician-determined retreatment strategy.

AIMS: To report the effectiveness of intravitreal ranibizumab treatment for neovascular age-related macular degeneration in a tertiary centre. METHODS: 1 year prospective cohort study of patients with a diagnosis of neovascular age-related macular degeneration on fundus fluorescein angiography treated with ranibizumab. Patients received three consecutive monthly treatments, followed by a clinician-determined re-treatment strategy. Data collected included demographic details, baseline and subsequent follow-up visit measurements, refraction protocol best corrected visual acuity (BCVA), contrast sensitivity (CS) and central foveal thickness (CFT) on optical coherence tomography. RESULTS: 81 patients were included in the study. The mean age was 79.5 years with a male:female ratio 32:49. The mean number of treatments was 5.6 ± 2.3. Visual outcomes at 12 months showed 17.1% gained ≥ 15 letters BCVA, 97.4% lost <15 letters and 2.5% lost ≥ 15 letters. Mean changes at 12 months were: BCVA +3.7 ± 11.1 (p<0.01); CS +2.3 ± 5.1 letters (p<0.001); CFT -100.1 ± 111.9 µm (p<0.001). CONCLUSIONS: Clinician-determined re-treatment after a three-dose initiation phase appears to be less effective in improving BCVA than in randomised controlled trials.