A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION.

PURPOSE: The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration. METHODS: Thirty subjects (46 eyes) were treated with the Valeda Light Delivery System, wherein subjects underwent two series of treatments (3× per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments. RESULTS: Photobiomodulation-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of ≥5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects (≥5-letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P < 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05). No device-related adverse events were reported. CONCLUSION: Photobiomodulation treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry age-related macular degeneration. Repeated PBM treatments are necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a safe and effective therapy in subjects with dry age-related macular degeneration.

Divergence in the lived experience of people with macular degeneration.

PURPOSE: The aim of this study was to understand people's experience with age-related macular degeneration (AMD) in light of new treatment successes. METHODS: An interpretive qualitative methodology was used to facilitate understanding of the experience of people with AMD. Rich in-depth data were collected using focus groups and individual interviews. Thematic analysis of the data occurred through the processes of line-by-line coding, aggregation, and theme development using the NVivo 10 software. RESULTS: A total of 4 focus groups and 16 individual interviews were conducted with 34 people (median age = 81 years; range = 56 to 102 years; 19 females) with AMD. Four major themes arose from the narratives of the participants: cautious optimism, enduring, adaptation, and profound loss. Cautious optimism resonated for participants who had received successful treatment and stabilization of AMD. Enduring emerged as participants with exudative AMD described an ongoing need for invasive and frequent treatments (anti-vascular endothelial growth factor injections) that maintained their vision. Adaptation was evident in the narratives of all participants and was directly related to the physical and psychological limitations that were a consequence of visual disability. Profound loss encompassed both physical and emotional aspects of deteriorating vision and was most evident in patients for whom treatment had failed or had not been considered appropriate for their disease. CONCLUSIONS: The findings of this study shed new light on the influence of underlying pathology, disease trajectory, and success of new treatments on quality of life of people living with AMD. Optimism toward maintaining vision in the presence of exudative AMD was described by participants, moderated by ongoing caution and a need for endurance of frequent and often problematic intravitreal treatments. These findings add a deeper understanding of this complex and life-changing experience.

Patient and public preferences for health states associated with AMD.

PURPOSE: Health utility values suitable for calculating quality-adjusted life-years are increasingly used to assess the cost-effectiveness of treatments for age-related macular degeneration (AMD). In the United States, health utilities are usually derived from the patients' own valuation or modeled using visual acuity as a surrogate outcome. In the United Kingdom and throughout Europe, health utilities are derived from public valuations. Our aim was to test if utility values for health states associated with AMD elicited directly from patients were different from those calculated from public tariffs for health-related quality of life (HRQoL) questionnaires. METHODS: Generic preference-based HRQoL questionnaires (EQ-5D and SF-6D) and the time trade-off (TTO) and visual analog scale (VAS) valuation techniques were administered to a sample of UK patients with AMD (N = 60). Health utilities were calculated using standard general population tariffs for the patient EQ-5D and SF-6D health states and directly from patient TTO and VAS scores. RESULTS: Mean utilities derived from the public tariffs were significantly higher than from patients' valuation (mean [±SD], 0.613 (±0.275) for the EQ-5D and 0.628 (±0.114) for the SF-6D compared with 0.481 [±0.411] for the TTO and 56.7 [±21.8] for the VAS score; p < 0.001). The EQ-5D was not significantly different from the SF-6D (p > 0.6). Visual acuity in the better seeing eye was not associated with any utility measure (all r < 0.08; p > 0.2). CONCLUSIONS: Patient and public preferences for health states associated with AMD are different, with patients valuing their health state more severely than the public tariffs of commonly used HRQoL questionnaires. Visual acuity did not predict health utility using any measure, and therefore, care should be taken when using visual acuity as a surrogate measure for utility in health economic analyses.