CATHAY ExtDOT Spectacle Lenses for Reducing Myopia in Chinese Children
Novel spectacle lens design
Eye Diseases
+ Myopia
+ Refractive Errors
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study aims to assess the safety and effectiveness of special glasses called Diffusion Optics Technology (DOT) spectacle lenses in slowing down the worsening of nearsightedness, or myopia, in children of Chinese descent. Myopia is a common vision problem where distant objects appear blurry, and it often worsens during childhood. The study is important because finding a way to slow down myopia progression can help prevent more severe vision problems later in life. Participants in this study will be randomly assigned to use the DOT spectacle lenses over a 12-month period. The study is open-label, meaning participants and researchers will know who is receiving the DOT lenses. However, the evaluators, who measure the outcomes, will not know who is wearing the lenses to ensure unbiased results. The study will take place at multiple centers, with regular check-ups to monitor children's eye health and measure changes in their vision. The main focus is to gather more information on the long-term safety and benefits of using these lenses in managing myopia in children.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.175 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 8 to 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
West China Hospital
Chengdu, ChinaFudan University EENT
Shanghai, ChinaTianjin Eye Hospital
Tianjin, China