Assessment of DOT Spectacles in Chinese Children Extension

Last updated: June 6, 2025
Sponsor: SightGlass Vision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

Novel spectacle lens design

Clinical Study ID

NCT07008001
CPRO-2201-002
  • Ages 8-16
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previously a successfully completed participant in the CATHAY study (NCT05562622)

  2. Agree to wear the assigned spectacles constantly except for sleeping, swimming, orother activities in which spectacle wear would be dangerous or otherwise notpossible (minimum of 10 hours per day)

  3. Willingness to participate in the trial for 12 months without contact lens wear orany other myopia management intervention

  4. The subject's parent(s) or legal guardian(s) must read, understand and sign theStatement of Informed Consent and receive a fully executed copy of the form

Exclusion

Exclusion Criteria:

  1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate

Study Design

Total Participants: 175
Treatment Group(s): 1
Primary Treatment: Novel spectacle lens design
Phase:
Study Start date:
June 30, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Aier Eye Hospital

    Changsha,
    China

    Active - Recruiting

  • West China Hospital

    Chengdu,
    China

    Active - Recruiting

  • Zhongshan Ophthalmic Center

    Guangzhou,
    China

    Site Not Available

  • Fudan University EENT

    Shanghai,
    China

    Active - Recruiting

  • Tianjin Eye Hospital

    Tianjin,
    China

    Active - Recruiting

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