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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Angie Adler
- Telefonnummer: 608-265-7557
- E-mail: amadler1@wisc.edu
Studiesteder
-
-
Wisconsin
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Madison, Wisconsin, Forenede Stater, 53715
- University of Wisconsin - Madison
-
Kontakt:
- Angie Adler
- Telefonnummer: 608-265-7557
- E-mail: amadler1@wisc.edu
-
Ledende efterforsker:
- Yasmin Bradfield, MD
-
-
-
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Bagmati Province
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Kathmandu, Bagmati Province, Nepal
- Tilganga Institute of Ophthalmology
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Kontakt:
- Srijana Adhikari
- E-mail: srij_a@yahoo.com
-
Ledende efterforsker:
- Srijana Adhikari
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 komparator: Placebo
Participants will receive placebo therapy |
Placebo device will match the RLRL in appearance but will not emit light. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in cycloplegic spherical equivalent refraction (SER)
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in rate of SER increase
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in rate of AL increase
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Best corrected visual acuity (BCVA)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
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Change in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) composite score
Tidsramme: 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)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in corneal curvature (CC)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
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Change in choroidal thickness (CT)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
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Change in White-to-White (WTW)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
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Change in choroidal structures
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
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Intraocular pressure (IOP)
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
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Ocular and systemic symptoms
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
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Ocular signs assessed by slit-lamp biomicroscopy and binocular indirect ophthalmoscopy
Tidsramme: Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yasmin Bradfield, MD, University of Wisconsin, Madison
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-1264
- AS (Anden identifikator: UW Madison)
- UWMSN | SMPH | Ophthalmology a (Anden identifikator: UW Madison)
- Protocol Version 8/22/2025 (Anden identifikator: UW Madison)
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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