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Active Not Recruiting
NCT05562622
Assessment of DOT Spectacles in Chinese Children
Conditions: Juvenile Myopia, Myopia
Sex: All
Ages: 6 Years – 13 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 195
Sponsor: SightGlass Vision, Inc.
Location: Aier Eye Hospital Changsha
Summary
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial 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 myopia in children of Chinese origin.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05562622). StuddyBuddy aggregates publicly available trial information.
