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NCT07008001 | RECRUITING | Juvenile Myopia

Assessment of DOT Spectacles in Chinese Children Extension
Sponsor:

SightGlass Vision, Inc.

Brief 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.

Condition or disease

Juvenile Myopia

Myopia

Intervention/treatment

Novel spectacle lens design

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 175 participants
Masking : SINGLE
Masking Description : Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked to participant's former treatment group.
Primary Purpose : TREATMENT
Official Title : Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 8 Years to 16 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
  • 3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
  • 4. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form
Exclusion Criteria
  • 1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Assessment of DOT Spectacles in Chinese Children Extension

Location Details

NCT07008001

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China,

Aier Eye Hospital

Changsha, China,

RECRUITING

China,

West China Hospital

Chengdu, China,

NOT YET RECRUITING

China,

Zhongshan Ophthalmic Center

Guangzhou, China,

RECRUITING

China,

Fudan university one

Shanghai, China,

RECRUITING

China,

Tianjin Eye Hospital

Tianjin, China,