Red-light therapy for highly myopic childre

Phase 2

• Conditions: High Myopia; Nearsightedness, High myopia, Children,; D009216

• Registration Number: JPRN-jRCTs032220339
• Lead Sponsor: Ohno Kyoko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Provision of consent
Age 8 years or older and less than or equal to 18 years old or younger at enrollment. High myopia cycloplegic sphere less than or equal to -6.00 dioptres in both eyes. Willing and able to participate in all required activities of the study. Normal Fundus , tessellated fundus or with peripapillary diffuse chorioretinal atrophy

Exclusion Criteria

The children undergoing or previously treated with myopia control treatments, eg orthokeratology, low dose atropine eye drops, multifocal soft contact lenses. However, children currently using only low dose atropine eye drops, can be recruited but atropine treatment should be discontinued for at least 2 weeks.

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 enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of AL shortening greater than 0.05mm at 12-month follow-up.