Repeated Low-Level Red-Light Therapy Shortens Axial Length

NCT05768152 | Unknown DMC

• 1 other identifier: (2022)-0131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.

Conditions

High Myopia; Axial Length; Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Incidence rate of axial length shortening greater than 0.05 mm

  Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.

  12 months

Secondary Outcomes (11)

• Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm

  12 months

• Magnitude of axial length shortening among shortened eyes

  12 months

• Changes in choroidal thickness (μm)

  1, 3, 6 and 12 months

• Changes in axial length (mm)

  1, 3, 6 and 12 months

• Changes in corneal curvature (mm)

  1, 3, 6 and 12 months

Study Arms (1)

Repeated low-level red-light (RLRL) therapy

EXPERIMENTAL

single vision spectacles \& RLRL

Device: RLRL

Interventions

RLRL DEVICE

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

Repeated low-level red-light (RLRL) therapy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Provision of consent.
• Age: ≥ 8 and ≤ 18 years at enrolment.
• High myopia: cycloplegic sphere of -6.00 diopters (D) or greater 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

• The Second People's Hospital of Foshan: lead

Study Sites (1)

The Second People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

MeSH Terms

Conditions

Eye Diseases

Central Study Contacts

Xiangbin Kong, MD, PhD

CONTACT

+8613929994766; xiangbin_kong@sina.com

Yanping Chen, MD

CONTACT

chenyp1_1@163.com

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: February 20, 2023
• First Posted: March 14, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)