Assessment of DOT Spectacles in Chinese Children Extension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-16
SponsorSightGlass Vision, Inc.
About this trial
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
Qualifiers
Previously a successfully completed participant in the CATHAY study (NCT05562622)
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)
Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Novel spectacle lens design
Treatment groups
175 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov