Assessment of DOT Spectacles in Chinese Children

N/AActive Not RecruitingNCT05562622

SightGlass Vision, Inc.195 enrolled

Overview

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration 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 juvenile myopia in children of Chinese origin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

195

Conditions

Juvenile Myopia Myopia

Interventions

Novel spectacle lens designDEVICE

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

Spectacle lensesDEVICE

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Axial length

Change in axial length from baseline

Time frame: 12 months

Data from ClinicalTrials.gov

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