Assessment of DOT Spectacles in Chinese Children
Not Applicable
Active, not recruiting
- Conditions
- Juvenile MyopiaMyopia
- Interventions
- Device: Spectacle lensesDevice: Novel spectacle lens design
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 195
Inclusion Criteria
- Children 6-13 years of age
- SER error between -0.75D and -5.00D
- Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear
Exclusion Criteria
- Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
- Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
- Anisometropia (SER manifest refraction) greater than 1.00 D
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Arm 2 Spectacle lenses Single vision, impact-resistant spectacle lenses SightGlass Vision Test Arm 1 Novel spectacle lens design Single vision, impact-resistant spectacle lenses
- Primary Outcome Measures
Name Time Method Axial length 12 months Change in axial length from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Aier Eye Hospital
🇨🇳Changsha, China
West China Hospital
🇨🇳Chengdu, China
Fudan University EENT
🇨🇳Shanghai, China
Zhongshan Ophthalmic Center
🇨🇳Guangzhou, China
Tianjin Eye Hospital
🇨🇳Tianjin, China