Active — Not RecruitingNot Applicable

Assessment of DOT Spectacles in Chinese Children

China195 participantsStarted 2023-02-05

Plain-language 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.

Who can participate

Age range6 Years – 13 Years

SexALL

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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

What they're measuring

Axial length

Timeframe: 12 months

Trial details

NCT IDNCT05562622

SponsorSightGlass Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Juvenile Myopia trials