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

N/AActive Not RecruitingNCT05550740

Shanghai Eye Disease Prevention and Treatment Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Myopia Refractive Errors Eye Diseases

Interventions

RLRLDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

Incidence rate of axial length shortening \> 0.10 mm and 0.20 mm are characterized as the ratio of number of participants with axial length hortening greater than 0.10 mm and 0.20 mm to the total number.

Time frame: 12 months

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

Changes of axial length shortening is characterized as the magnitude of axial length reduction among axial shortened eyes.

Time frame: 12 months

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

Changes in choroidal structural and perfusion parameters are characterized as the difference between each follow-up visit and corresponding baseline values. Indicators include choroidal vascular index, choroidal thickness and so on.

Time frame: 1, 3, 6 and 12 months

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

Swept-source optical coherence tomography is used to measure retinal structures. The structures of nerve sensory layer, retinal pigment epithelium layer and choroid layer were observed by fundus images.

Time frame: 1, 3, 6 and 12 months

Data from ClinicalTrials.gov

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