The EYERISING Study
Repeated Low-level Red Light for Myopia Progression Study: An International, Multicenter, Multiethnic, Randomized Controlled Trial, IPOSC Study
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:
- Can RLRL therapy help slow down the worsening of myopia?
Participants will use a red-light therapy investigational device at home, 5 days a week for 12 months.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Angie Adler
- Telefonnummer: 608-265-7557
- E-post: amadler1@wisc.edu
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53715
- University of Wisconsin - Madison
-
Kontakt:
- Angie Adler
- Telefonnummer: 608-265-7557
- E-post: amadler1@wisc.edu
-
Huvudutredare:
- Yasmin Bradfield, MD
-
-
-
-
Bagmati Province
-
Kathmandu, Bagmati Province, Nepal
- Tilganga Institute of Ophthalmology
-
Kontakt:
- Srijana Adhikari
- E-post: srij_a@yahoo.com
-
Huvudutredare:
- Srijana Adhikari
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age ≥ 6 and ≤ 12 (at screening)
- Myopia: Cycloplegic SER -1.0 to -7.0 D
- Astigmatism: < 1.5 D
- Anisometropia: < 1.5 D
- Informed parental consent
- Consistent access to wireless internet
Exclusion Criteria:
-
A subject who is born female and who is currently menstruating or has begun menstruation (menarche).
- Ophthalmic diseases, conditions, or syndromes other than refractive errors
- Previous use of treatment for myopia control (e.g., defocusing lenses or contact lenses, orthokeratology, atropine, and pirenzepine)
- Any previous ocular surgery
- Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies
- Inability to attend regular follow up visits
- Participants with any symptom, disease, or other condition that, in the opinion of the investigators, may affect the effectiveness of the investigational treatment and/or the ability of the participant to complete study activities
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Red light therapy
Participants will receive red light therapy |
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-jämförare: Placebo
Participants will receive placebo therapy |
Placebo device will match the RLRL in appearance but will not emit light. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in cycloplegic spherical equivalent refraction (SER)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
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. |
Baseline, 4 months, 8 months, 12 months
|
|
Change in axial length (AL)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
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. |
Baseline, 4 months, 8 months, 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in rate of SER increase
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in rate of AL increase
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Best corrected visual acuity (BCVA)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) composite score
Tidsram: Baseline, 4 months, 8 months, 12 months
|
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. |
Baseline, 4 months, 8 months, 12 months
|
|
Change in anterior chamber depth (ACD)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in corneal curvature (CC)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in choroidal thickness (CT)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in White-to-White (WTW)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in choroidal structures
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Intraocular pressure (IOP)
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Ocular and systemic symptoms
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Ocular signs assessed by slit-lamp biomicroscopy and binocular indirect ophthalmoscopy
Tidsram: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yasmin Bradfield, MD, University of Wisconsin, Madison
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-1264
- AS (Annan identifierare: UW Madison)
- UWMSN | SMPH | Ophthalmology a (Annan identifierare: UW Madison)
- Protocol Version 8/22/2025 (Annan identifierare: UW Madison)
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