Assessment of DOT Spectacles in Chinese Children Extension

Not Applicable

Recruiting

• Conditions: Juvenile Myopia; Myopia

• Registration Number: NCT07008001
• Lead Sponsor: SightGlass Vision, Inc.

Brief Summary

This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-28
• Status Verified: 2025-06
• Study First Posted: 2025-06-06
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-11
• Study Start: 2025-06-30
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

1. Previously a successfully completed participant in the CATHAY study (NCT05562622)
2. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
4. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form

Exclusion Criteria

1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial length Group II	12 months	Change in axial length from baseline to 12 months
Axial length Group I	12 months	Change in axial length from baseline to 36 months

Trial Locations

Locations (5)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, China

Aier Eye Hospital; 🇨🇳 Changsha, China

West China Hospital; 🇨🇳 Chengdu, China

Fudan University EENT; 🇨🇳 Shanghai, China

Tianjin Eye Hospital; 🇨🇳 Tianjin, China