Shanghai Eye Disease Prevention and Treatment Center
Phase
Not applicable
Started
2022-11-19
Last updated
2025-03-30
Condition(s) studied
High MyopiaRefractive ErrorsEye Diseases
Investigational drug(s) / intervention(s)
RLRL
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.
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
16 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master — 12 months 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
Shanghai Municipality
More Shanghai Eye Disease Prevention and Treatment Center trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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