Assessment of DOT Spectacles in Chinese Children Extension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel spectacle lens design.
- Who it may be relevant to
- Registry conditions: Juvenile Myopia, Myopia. Basic parameters: 8 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
Overview
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.
Interventions
- Device Novel spectacle lens design
Use of spectacle lenses may reduce the rate of progression of juvenile myopia
Primary outcome measures
- Axial length Group I [Time frame: 12 months]
- Axial length Group II [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
1\. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Aier Eye Hospital — Changsha
- West China Hospital — Chengdu
- Zhongshan Ophthalmic Center — Guangzhou
- Fudan University EENT — Shanghai
- Tianjin Eye Hospital — Tianjin
Identifiers
NCT: NCT07008001 · CPRO-2201-002