Effectiveness of optical treatment in amblyopia and validation of measuring spectacle compliance with the ODM

Purpose: The improvement in visual acuity (VA) was determined during optical treatment in children with amblyopia before their participation in a randomised clinical trial comparing the effect of dichoptic video gaming using virtual reality goggles with occlusion therapy. Methods: Children aged 4–12 years with an interocular VA difference ≥0.20 logMAR and an amblyogenic factor: strabismus &lt;30Δ, ≥1.00 D anisometropia, astigmatism ≥1.50 D and/or hypermetropia ≥1.50 D were eligible for 16 weeks of optical treatment. Children with previous amblyopia treatment were excluded. Compliance with spectacle wear was measured electronically over 1 week using the occlusion dose monitor (ODM). The reliability of these measurements was verified. The main outcome was an increase in amblyopic eye VA from baseline to 16 weeks. Results: Sixty-five children entered the optical treatment period. Mean age was 6.0 ± 2.2 years (range: 4–12 years; IQR 4.5–6.7 years). Amblyopia was caused by anisometropia in 53 (82%) children, strabismus in 6 (9%) and combined mechanism in 6 (9%). After optical treatment, mean VA improved by 0.20 logMAR (SD 0.28; p &lt; 0.001) and 0.07 in the amblyopic and fellow eye, respectively (SD 0.20; p = 0.03). This resulted in 24 children (37%) with an interocular VA difference &lt;0.20 logMAR and in 17% of children with VA at the start of 0.30 logMAR or worse. Poor VA in the amblyopic eye at baseline (p = 0.001) and high anisometropia (p = 0.001) were associated with VA improvement. On average, spectacles were worn 9.7 ± 2.4 h/day (range: 2.3–13.6 h); mean compliance was 73% ± 18% of estimated wake time. Only ambient temperature ≥ 31°C or when spectacles were worn on top of the head prevented a reliable ODM measurement. Conclusions: VA improved by two lines resulting in more than a third of the children being treated sufficiently with spectacles alone and no longer being classified as amblyopic. The ODM proved to be a reliable method of measuring compliance with spectacle wear.</p

Supervised dichoptic gaming versus monitored occlusion therapy for childhood amblyopia: Effectiveness and efficiency

PurposeTo compare the effectiveness and efficiency of supervised dichoptic action-videogame play to occlusion therapy in children with amblyopia.MethodsNewly diagnosed children with amblyopia aged 4-12 years were recruited, excluding strabismus &gt;30PD. After 16 weeks of refractive adaptation children were randomized to gaming 1 h/week supervised by the researcher, or electronically monitored occlusion 2 h/day. The gaming group played a dichoptic action-videogame using virtual reality goggles, which included the task of catching a snowflake presented intermittently to the amblyopic eye. Contrast for the fellow eye was self-adjusted until 2 identical images were perceived. The primary outcome was visual acuity (VA) change from baseline to 24 weeks.ResultsWe recruited 96 children, 29 declined and 2 were excluded for language or legal issues. After refractive adaptation, 24 of the remaining 65 no longer met the inclusion criteria for amblyopia, and 8 dropped out. Of 16 children treated with gaming, 7 (6.7 years) completed treatment, whereas 9 younger children (5.3 years) did not. Of 17 treated with occlusion, 14 (5.1 years) completed treatment and 3 (4.5 years) did not. Of 5 children with small-angle strabismus, 3 treated with occlusion completed treatment and 2 treated with gaming did not. Median VA improved by 0.30 logMAR (IQR 0.20-0.40) after gaming, 0.20 logMAR (0.00-0.30) after occlusion (p = 0.823). Treatment efficiency was 1.25 logMAR/100 h (range 0.42-2.08) with gaming, 0.08 (-0.19-0.68) with occlusion (p &lt; 0.001).ConclusionDichoptic gaming seems a viable alternative for older children with refractive amblyopia after glasses adaptation. Treatment efficiency with gaming under continuous supervision was 15 times higher than with occlusion at home

Supervised dichoptic gaming versus monitored occlusion therapy for childhood amblyopia: Effectiveness and efficiency

Purpose: To compare the effectiveness and efficiency of supervised dichoptic action-videogame play to occlusion therapy in children with amblyopia. Methods: Newly diagnosed children with amblyopia aged 4–12 years were recruited, excluding strabismus >30PD. After 16 weeks of refractive adaptation children were randomized to gaming 1 h/week supervised by the researcher, or electronically monitored occlusion 2 h/day. The gaming group played a dichoptic action-videogame using virtual reality goggles, which included the task of catching a snowflake presented intermittently to the amblyopic eye. Contrast for the fellow eye was self-adjusted until 2 identical images were perceived. The primary outcome was visual acuity (VA) change from baseline to 24 weeks. Results: We recruited 96 children, 29 declined and 2 were excluded for language or legal issues. After refractive adaptation, 24 of the remaining 65 no longer met the inclusion criteria for amblyopia, and 8 dropped out. Of 16 children treated with gaming, 7 (6.7 years) completed treatment, whereas 9 younger children (5.3 years) did not. Of 17 treated with occlusion, 14 (5.1 years) completed treatment and 3 (4.5 years) did not. Of 5 children with small-angle strabismus, 3 treated with occlusion completed treatment and 2 treated with gaming did not. Median VA improved by 0.30 logMAR (IQR 0.20–0.40) after gaming, 0.20 logMAR (0.00–0.30) after occlusion (p = 0.823). Treatment efficiency was 1.25 logMAR/100 h (range 0.42–2.08) with gaming, 0.08 (−0.19–0.68) with occlusion (p < 0.001). Conclusion: Dichoptic gaming seems a viable alternative for older children with refractive amblyopia after glasses adaptation. Treatment efficiency with gaming under continuous supervision was 15 times higher than with occlusion at home

Clinical evidence for use of a non-invasive biosensor for tear glucose as an alternative to painful finger-prick for diabetes management utilizing biopolymer coating

Diabetes is a metabolic condition that is exponentially increasing worldwide. Current monitoring methods for diabetes are invasive, painful, and expensive. Herein, we present the first multipatient clinical trial that demonstrates clearly that tear fluid may be a valuable marker for systemic glucose measurements. The NovioSense Glucose Sensor, worn under the lower eye lid (inferior conjunctival fornix), is reported to continuously measure glucose levels in the basal tear fluid with good correlation to blood glucose values, showing clear clinical feasibility in both animals and humans. Furthermore, the polysaccharide coated device previously reported by our laboratory when worn, does not induce pain or irritation. In a phase II clinical trial, six patients with type 1 Diabetes Mellitus were enrolled and the capability of the device to measure glucose in the tear fluid was evaluated. The NovioSense Glucose Sensor gives a stable signal and the results correlate well to blood glucose values obtained from finger-prick measurements determined by consensus error grid analysis

Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients:ESCRS PREMED study report 6

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in diabetic patients. SETTING: Seven ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n=163) undergoing uncomplicated cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n=36), perioperative intravitreal bevacizumab (n=36), combination treatment (n=45), or no additional treatment (control group, n=46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: Mean total healthcare costs and QALYs were: Triamcinolone € 1827 (US$2295) / 0.166; Bevacizumab € 2050 (US$ 2575) / 0.144; Combination € 2027 (US$2546) / 0.166; Control € 2041 (US$ 2564) / 0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was € 321,984 (US$404,503) per QALY for the combination group compared to the triamcinolone group. Assuming the willingness-to-pay is € 20,000 (US$ 25,126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient that received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed triamcinolone is also cost-effective