Bright Light and Combination of Myopic Defocus for Myopia Control: Study Design and Demographic Data

Abstract

Purpose : Bright light has been shown to inhibit myopic eye growth in animals, and outdoor activities under direct sunlight have also been suggested to have a protective effect against myopia. We hypothesize that a home-based desktop device that mimics sunlight could slow myopia progression in schoolchildren.

Methods : A 2-year prospective, double-blinded, and randomized clinical trial was initiated to investigate the myopia control effect using bright light and combination therapy (ClinicalTrials.gov: NCT04923841). The study design and demographic data of the first phase was presented.
Chinese schoolchildren aged 7 to 12 years with a spherical equivalent refraction (SER) between -0.75 and -5.00D, astigmatism, and anisometropia below 1.75D were recruited. Subjects were age-stratified and randomly allocated into three groups. The treatment device was a desktop lamp with a 10,000-lux White LED light source. Control group (G1) received a 500-lux placebo lamp and single-vision (SV) spectacles; monotherapy group (G2) received the treatment lamp and SV spectacles; and combination therapy group (G3) received the treatment lamp and Defocus Incorporated Multiple Segments (DIMS) spectacles. Subjects were instructed to wear the spectacles full time and use the desktop lamp for 45–120 mins per day. The primary outcome measures were the change in cycloplegic autorefraction in SER and axial length (AL) over 2 years from baseline. Safety and tolerability of the treatment were closely monitored.

Results : A total of 401 eligible subjects were successfully enrolled after a 1-month adaptation period (G1: n=135; G2: n=135; G3: n=131). Data from the right eyes were used for analyses. In younger age group, there were no significant differences in AL and mean keratometry (meanK) among 3 groups (p>0.05), but subjects in G3 were more myopic than those in G1 (p=0.045). In older age group, there were no significant differences in SER, AL and meanK between groups (p>0.05). The baseline characteristics are shown in Table 1. No device-related serious adverse events have been reported.

Conclusions : This is the first randomized clinical trial to determine the effectiveness of bright light and combination therapy in inhibiting myopia progression in schoolchildren. One-year results will be shared in the third quarter of 2024.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.

 

Table 1. Baseline demographics data of subjects in sub-age groups.