Assessment of DOT Spectacles in Chinese Children

Not Applicable

Active, not recruiting

• Conditions: Juvenile Myopia; Myopia

• Registration Number: NCT05562622
• Lead Sponsor: SightGlass Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-10-03
• Study Start: 2023-02-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 195

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial length	12 months	Change in axial length from baseline

Trial Locations

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