Assessment of DOT Spectacles in Chinese Children Extension
CATHAY Ext
Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
1 other identifier
interventional
175
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
June 6, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
December 29, 2025
December 1, 2025
1.2 years
May 14, 2025
December 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Axial length Group I
Change in axial length from baseline to 36 months
12 months
Axial length Group II
Change in axial length from baseline to 12 months
12 months
Study Arms (2)
SightGlass Vision Test Arm Groups I (formerly test group)
EXPERIMENTALSingle vision, impact-resistant spectacle lenses
SightGlass Vision Test Arm Groups II (formerly control group)
EXPERIMENTALSingle vision, impact-resistant spectacle lenses
Interventions
Use of spectacle lenses may reduce the rate of progression of juvenile myopia
Eligibility Criteria
You may qualify if:
- Previously a successfully completed participant in the CATHAY study (NCT05562622)
- 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)
- Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
- 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
You may not qualify if:
- \. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked to participant's former treatment group.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2025
First Posted
June 6, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12