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

NCT ID: NCT05550740

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-19
• Study Completion Date: 2026-03-23

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.

Detailed Description

High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. RLRL therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.

The purpose of this study is to confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.

Conditions

High Myopia; Refractive Errors; Eye Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RLRL therapy

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

Group Type: EXPERIMENTAL

RLRL

Intervention Type: 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.

Interventions

RLRL

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Provision of consent.

2. Age: ≥ 6 and ≤ 16 years at enrolment.

3. High myopia: cycloplegic sphere ≤ -6.00 diopters (D) in both eyes.

4. Willing and able to participate in all required activities of the study.

5. 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.

6. Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.

Exclusion Criteria

1. 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.

2. Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.

3. Strabismus and binocular vision abnormalities in either eye.

4. Previous any intraocular surgery affecting refractive status.

5. Other reasons, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HMRL-SEPTC-2022

Identifier Type: -

Identifier Source: org_study_id