Assessment of DOT Spectacles in Chinese Children Extension

Sponsor
SightGlass Vision, Inc.
Study ID
NCT07008001
Status
Recruiting
Apply to this trial

Conditions

  • Juvenile Myopia
  • Myopia

Eligibility Criteria

Sex
ALL
Age
8 Years - 16 Years
Healthy Volunteers
Accepted

Interventions

  • Novel spectacle lens design — DEVICE
    Use of spectacle lenses may reduce the rate of progression of juvenile myopia

Study Details

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.

Key Dates

First listed
Jun 6, 2025
Start date
Aug 1, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
175 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SightGlass Vision Test Arm Groups I (formerly test group)
    Single vision, impact-resistant spectacle lenses
  • Experimental: SightGlass Vision Test Arm Groups II (formerly control group)
    Single vision, impact-resistant spectacle lenses

Primary Outcome Measure

Axial length Group I [ Time Frame: 12 months ]

Central Contacts

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