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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Novel spectacle lens design
DeviceUse of spectacle lenses may reduce the rate of progression of juvenile myopia
Treatment groups
175 Participants
are divided into 2 treatment groupsGroup A: SightGlass Vision Test Arm Groups I (formerly test group)Experimental treatment 1 intervention
Group B: SightGlass Vision Test Arm Groups II (formerly control group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Axial length Group I
Change in axial length from baseline to 36 months
Time frame
12 months2
Axial length Group II
Change in axial length from baseline to 12 months
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov