Continued use of DOT spectacle lenses for Chinese children

Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension

This will test whether DOT spectacle lenses slow myopia progression over 12 months in Chinese children who completed the earlier CATHAY study.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 175 (estimated)
• Ages: 8 Years to 16 Years
• Sex: All
• Sponsor: SightGlass Vision, Inc. (Industry-sponsored)
• Locations: 5 sites (Changsha and 4 other locations)
• Trial ID: NCT07008001 on ClinicalTrials.gov

What this trial studies

This is a 12-month, randomized, controlled, open-label, evaluator-blinded, multicenter extension enrolling Chinese children who successfully completed the CATHAY trial. Participants are randomly assigned to wear DOT spectacle lenses and are asked to wear them at least 10 hours per day while avoiding contact lenses or other myopia-control interventions. Outcome assessors are blinded, and the trial continues safety monitoring while measuring refractive change and axial length to determine lens effect on myopia progression. The study is conducted at three major ophthalmic centers in China.

Who should consider this trial

Good fit: Ideal candidates are Chinese children who completed the CATHAY study, whose parents provide informed consent, and who can commit to wearing the assigned spectacles for at least 10 hours daily and avoiding other myopia treatments for 12 months.

Not a fit: Children with known allergies to proparacaine, tetracaine, tropicamide, or cyclopentolate, or those unable or unwilling to wear the spectacles daily or to avoid other myopia therapies, are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, DOT lenses could slow juvenile myopia progression and help reduce the need for more invasive or intensive treatments later in life.

How similar studies have performed: This extension follows the CATHAY trial of DOT lenses, and other optical lens approaches for myopia control have shown promising but variable success in slowing childhood myopia.

Eligibility 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

Where this trial is running

Changsha and 4 other locations

• Aier Eye Hospital — Changsha, China (Recruiting)
• West China Hospital — Chengdu, China (Recruiting)
• Zhongshan Ophthalmic Center — Guangzhou, China (Not_yet_recruiting)
• Fudan University EENT — Shanghai, China (Recruiting)
• Tianjin Eye Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Jennifer S Hill, BS

Conditions Juvenile Myopia; Myopia