Assessment of DOT Spectacles in Chinese Children

NCT05562622 · tracked via the Priya Life Science China tracker

Sponsor

SightGlass Vision, Inc.

Phase

Not applicable

Started

2023-02-05

Last updated

2026-07-13

Condition(s) studied

Juvenile MyopiaMyopia

Investigational drug(s) / intervention(s)

Novel spectacle lens designSpectacle lenses

Novel spectacle lens design: Use of lenses may reduce the rate of progression of juvenile myopia

Spectacle lenses: Use of lenses may reduce the rate of progression of juvenile myopia

Study summary

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of myopia in children of Chinese origin.

Eligibility

Sex

ALL

Min age

6 Years

Max age

13 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Children 6-13 years of age 2. SER error between -0.75D and -5.00D 3. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear Exclusion Criteria: 1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K) 2. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye 3. Anisometropia (SER manifest refraction) greater than 1.00 D

Primary outcome measure(s)

Axial length — 12 months
Change in axial length from baseline

Trial sites (5)

Facility	City	Region
Aier Eye Hospital	Changsha	China
West China Hospital	Chengdu	China
Zhongshan Ophthalmic Center	Guangzhou	China
Fudan University EENT	Shanghai	China
Tianjin Eye Hospital	Tianjin	China

More SightGlass Vision, Inc. trials in China

Assessment of DOT Spectacles in Chinese Children Extension Recruiting

Other trials for the same condition

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A Randomized Controlled Trial Comparing Clinical Effectiveness of SMILE Versus SMILE Xtra in Myopia Recruiting

Impact of Ultraviolet Radiation and Environmental Factors on Human Ocular Biomechanics Active, not recruiting

Evaluation of a County-Based Eye Health Service Model in Rural Chinese Children Recruiting

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 NCT05562622 on ClinicalTrials.gov ↗ ← All trials in China