Myopia Control Combined PBM With Myopic Defocus Lens in Children

NCT05756959 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Airdoc Technology Co., Ltd.

Phase

Not applicable

Started

2022-12-12

Last updated

2023-03-09

Condition(s) studied

Myopia, Progressive

Investigational drug(s) / intervention(s)

PBMPeripheral defocus spectaclesSingle vision spectacles

PBM: PBM, is a low intensity red light at wavelength of 650nm; Peripheral defocus spectacels is a peripheral design glasseses for correct myopia and control myopia

Peripheral defocus spectacles: plus power design of many peripheral small lenses to achieve myopic defocus of the retina in the peripheral retina

Single vision spectacles: Distance vision correction with the single vision spectacles for the myopia correction methods (glasseses for myopia correction)

Study summary

To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.

Eligibility

Sex

ALL

Min age

6 Years

Max age

13 Years

Healthy volunteers

Inclusion Criteria: * Informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * SE range: -0.50\~-5.50D * Astigmatism \<=2.00D * BCVA \>=0.8 * Anisometropia \<=1.50D * Confirmed to no use of other myopia control intervention Exclusion Criteria: * Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * Halo, glare, toutic, ADHD, psoriasis * Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * Squint, ocular lesion or acute imflammation. * Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, multi-focus soft lens, multi-function spectacles.

Primary outcome measure(s)

axial length (mm) — 6 month
Axial length changes at follow-up of 6 month from baseline will be measured by IOLmaster 500 at the same site by the same examiner with the mean values of 5 times measurements at either time. Changes in axial length (mm) without cycloplegia are to be measured by IOLmaster(Carl Zeiss). Five measurements will be taken and then averaged.
SE (Diopter, D) — 6 month
changes of cycloplegic spherical equivalent from baseline will be measured under cycloplegic refraction by autorefractor. Five measured by the same autorefractor are to be obtained for each eye.

Trial sites (1)

Facility	City	Region	Status
the first people's hospital of Xuzhou	Xuzhou	Jiangsu	Recruiting

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Other trials for the same condition

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Multicenter RCT: LED Red Light Dose-Response in Myopia Progression Control Starting soon

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Official registry record

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.

View NCT05756959 on ClinicalTrials.gov ↗ ← All trials in China