Abstract
Purpose: :
To compare the performance of ready-made spectacles (RMS) and custom spectacles (CS) in an adult population in India with uncorrected refractive error (URE) using patient-reported outcome measures.
Methods: :
We included 363 adults aged 18-45 years with ≥1 diopter (D) of URE in a prospective double-masked randomized clinical trial with one month follow-up (RMS, n = 183; CS, n = 180). Participants were randomized to receive their full sphero-cylindrical correction (CS) or the spherical equivalent for the eye with lower refractive error, from a limited RMS inventory. Outcomes were assessed using a validated Visual Function and Quality of Life Instrument and participant satisfaction scale.
Results: :
In the full sample, Rasch scores for visual function and quality of life increased from an average of 1.14 to 4.37 logits in the RMS group, and from an average of 1.11 to 4.72 logits in the CS group (Respective mean change 3.23 vs. 3.61; p = 0.08). When subjects with high astigmatism or anisometropia were excluded, mean Rasch score improvements were similar (RMS = 3.58; CS = 3.55; p=0.87) Mean patient satisfaction also increased by 1.83 points on a 5-point Likert scale in the RMS group and 2.04 points in the CS group (p = 0.12).
Conclusions: :
Ready-made spectacles produce similar changes in the patient-reported outcomes of visual function, quality of life, and satisfaction with vision at one-month follow-up when compared to custom spectacles. This study supports more widespread use of ready-made spectacles in settings where custom spectacles are unavailable or unaffordable and refractive services are inaccessible to those in need.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00657670
Keywords: refraction • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • quality of life