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NCT05562622 Clinical Trial

Assessment of DOT Spectacles in Chinese Children

Myopia Clinical Trial

— CATHAY  

Official title:
Clinical Assessment of DOT Spectacle Lenses in Chinese Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05562622
Other study ID # CPRO-2201-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 5, 2023
Est. completion date December 30, 2025

Study information
Verified date April 2024
Source SightGlass Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 195
Est. completion date December 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
China Aier Eye Hospital Changsha
China West China Hospital Chengdu
China Zhongshan Ophthalmic Center Guangzhou
China Fudan University EENT Shanghai
China Tianjin Eye Hospital Tianjin

Sponsors (1)
Lead Sponsor Collaborator
SightGlass Vision, Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Axial length Change in axial length from baseline 12 months
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