An interventional study of Repeated Low-Level Red Light (RLRL) therapy and Placebo Device in Myopia, Astigmatism and Anisometropia, sponsored by University of Wisconsin, Madison. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Treatment
The purpose of this clinical trial is to see if and how well Repeated Low-Level Red Light (RLRL) therapy works to control myopia over 12 months. The main question it aims to answer is:
Participants will use a red-light therapy investigational device at home, 5 days a week for 12 months.
1,010 studies on the registry are indexed under Myopia; 212 are open to participants now.
This study's planned enrollment of 333 is above the median of 80 across 804 interventional studies indexed under Myopia.
Browse Myopia studies →University of Wisconsin, Madison is the lead sponsor of 1,187 studies on the registry; 182 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A subject who is born female and who is currently menstruating or has begun menstruation (menarche).
Participants will receive red light therapy
Device: Repeated Low-Level Red Light (RLRL) therapy
Participants will receive placebo therapy
Device: Placebo Device
RLRL device emits low-level red-light with a wavelength of 650 ± 10 nm. The device provides light at a power of 2.00 ± 0.50 mW.
Placebo device will match the RLRL in appearance but will not emit light.
Change in cycloplegic spherical equivalent refraction (SER)
SER will be measured using an autorefractometer after eye drops are given to temporarily relax the eye's focusing muscles. SER, measured in diopters (D), represents the amount of nearsightedness and will be used to measure the change in myopia from baseline.
Time frame: Baseline, 4 months, 8 months, 12 months
Change in axial length (AL)
AL will be measured using the IOLMaster and reported in millimeters (mm). Change in AL from baseline will be used to assess ocular growth/myopia progression.
Time frame: Baseline, 4 months, 8 months, 12 months
Change in rate of SER increase
Time frame: Baseline, 4 months, 8 months, 12 months
Change in rate of AL increase
Time frame: Baseline, 4 months, 8 months, 12 months
Best corrected visual acuity (BCVA)
Time frame: Baseline, 4 months, 8 months, 12 months
Change in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) composite score
The NEI VFQ-25 is a 25-item questionnaire assessing vision-related functioning and quality of life. The composite score ranges from 0 to 100, with higher scores indicating better visual functioning and vision-related quality of life.
Time frame: Baseline, 4 months, 8 months, 12 months
Change in anterior chamber depth (ACD)
Time frame: Baseline, 4 months, 8 months, 12 months
Change in corneal curvature (CC)
Time frame: Baseline, 4 months, 8 months, 12 months
Change in choroidal thickness (CT)
Time frame: Baseline, 4 months, 8 months, 12 months
Change in White-to-White (WTW)
Time frame: Baseline, 4 months, 8 months, 12 months
Change in choroidal structures
Time frame: Baseline, 4 months, 8 months, 12 months
Intraocular pressure (IOP)
Time frame: Baseline, 4 months, 8 months, 12 months
Ocular and systemic symptoms
Time frame: Baseline, 4 months, 8 months, 12 months
Ocular signs assessed by slit-lamp biomicroscopy and binocular indirect ophthalmoscopy
Time frame: Baseline, 4 months, 8 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for May 2029, 29 months later.
Of 196 non-industry interventional studies with no phase under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 29 months is above that.
Counting every sponsor, half of 381 studies reached it within 19 months; a quarter within 5 and three quarters within 37.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Oct 2026 → Dec 2026, primary completion Mar 2029 → May 2029 and completion Mar 2029 → May 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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