Abstract
Purpose: :
Evidence is limited on the extent to which health state utility decrements differ between changes in the better-seeing and worse-seeing eyes following treatment. This study presents estimates of the utility levels as a function of the visual acuity in the treated eye stratified by the condition of the fellow (untreated) eye in patients treated for visual impairment caused by diabetic macular edema (DME).
Methods: :
Data from RESTORE clinical trial with (12 months follow up of ranibizumab treatment for DME) were analyzed. 8 health states were defined by BCVA in the treated eye. Mean utility was estimated using multivariate regression (repeated measures analysis). The regression was tested for confounders including disease severity. The influence of BCVA in the fellow eye on the health index was explored by separating treated eyes into cohorts according to visual acuity of the fellow eye: better, equal or worse. Results were compared with other published studies.
Results: :
The utility ranged from 0.86 (SE=0.014) with BCVA 76-100 letters (LogMAR scores) to 0.55 (SE=0.083) with BCVA 0-25 letters (unadjusted model). Disease severity had a non-significant effect on this range (p>0.05). BCVA of the worse seeing eye had a significant impact on the utility (utility decrement -0.11 from 76-100 letters to 36-45 letters), with better seeing eyes demonstrating a utility decrement -0.14 from 76-100 letters to 36-45 letters. Results were inconclusive for health states below 35 letters due to small numbers.
Conclusions: :
This explorative analysis reveals that visual acuity of a worse seeing eye has a significant impact on utility which may be comparable to the impact on the better seeing eye. Importantly, these utility changes are supported by improvements in quality of life observed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) for DME patients treated with ranibizumab in the worse seeing eye in RESTORE.
Clinical Trial: :
https://eudract.ema.europa.eu 2007-004877-24
Keywords: visual acuity • edema • clinical (human) or epidemiologic studies: health care delivery/economics/manpower