Effect of Repeated Low-Level Red-Light Therapy on Retinal Function and Structure

NCT05597397 | Completed DMC

• 1 other identifier: RLS-SEPTC-2022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the effect of repeated low-level red-light (RLRL) therapy on the retinal function and structure among myopic teenagers.

Conditions

Myopia; Refractive Errors; Eye Diseases; Retina; Change

Outcome Measures

Primary Outcomes (2)

• Changes in the amplitudes of waves.

  Changes in the amplitudes are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.

  1 and 2 months

• Changes in the latency of waves.

  Changes in the latency of waves are characterized as the difference between each follow-up visit and corresponding baseline values which are measured by electroretinogram.

  1 and 2 months

Secondary Outcomes (8)

• Changes in retinal sensitivity

  1 and 2 months

• Changes in fixation stability

  1 and 2 months

• Changes in macular integrity

  1 and 2 months

• Changes in macular vessel density

  1 and 2 months

• Changes in macular perfusion density

  1 and 2 months

Study Arms (1)

Repeated Low-Level Red-Light Therapy (RLRL)

EXPERIMENTAL

Single vision spectacles (SVS) \& RLRL.

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.

Repeated Low-Level Red-Light Therapy (RLRL)

Eligibility Criteria

• Age: 15 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age: 15-16 years at enrolment.
• Myopia: cycloplegic spherical equivalent refractions (SERs) range from -1.00 to -5.00 diopters (D) and astigmatism less than -2.5 D in either eye.
• Best corrected visual acuity equal to or better than 0.8 in either eye.
• Normal fundus, or tessellated fundus.
• Provision of consent and able to participate in all required activities of the study.

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.
• Strabismus and binocular vision abnormalities in either eye.
• Refractive media opacity: corneal opacities, cataract, or implanted intraocular lens, etc.
• Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
• Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
• Systemic abnormalities: diabetes, hypertension, etc.
• Drugs therapies with toxicity effect on the retina: hydroxychloroquine, etc.
• Prior treatment of myopia control in the past three months, drugs, orthokeratology, progressive addition lenses, bifocal lens, etc.
• Other contraindications, 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

Myopia; 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: October 28, 2022
• Study Start: March 1, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)