Repeated Low-Level Red-Light Therapy for Shortening Axial Length

NCT05550740 | Active Not Recruiting DMC

• 1 other identifier: HMRL-SEPTC-2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese high myopia children and teenagers.

Conditions

High Myopia; Refractive Errors; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master

  Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.

  12 months

Secondary Outcomes (9)

• Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master

  12 months

• Changes of axial length shortening (mm) among shortened eyes measured the IOL master

  12 months

• Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography

  1, 3, 6 and 12 months

• Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography

  1, 3, 6 and 12 months

• Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master

  1, 3, 6 and 12 months

Other Outcomes (6)

• Full myopia control rate (%) by the autorefractor

  36 months

• Morphological changes of the posterior ocular segment by the quantitative ultrawide-field optical coherence tomography

  36 months

• Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master

  36 months

Study Arms (1)

RLRL therapy

EXPERIMENTAL

In addition to SVS, participants will be treated with RLRL twice a school day.

Device: RLRL

Interventions

RLRL DEVICE

In addition to SVS with power for correcting distance refraction, RLRL will be performed twice per school day with an interval of at least 4 hours, each treatment last 3 minutes.

RLRL therapy

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Provision of consent.
• Age: ≥ 6 and ≤ 16 years at enrolment.
• High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.
• Willing and able to participate in all required activities of the study.
• The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
• Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.

You may not qualify if:

• Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
• Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
• Strabismus and binocular vision abnormalities in either eye.
• Previous any intraocular surgery affecting refractive status.
• Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 20041, China

Location

MeSH Terms

Conditions

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: November 19, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 23, 2026
• Last Updated: March 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)