Recruiting

CATHAY ExtDOT Spectacle Lenses for Reducing Myopia in Chinese Children

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What is being tested

Novel spectacle lens design

Device
Who is being recruted

Eye Diseases

+ Myopia

+ Refractive Errors

From 8 to 16 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorSightGlass Vision, Inc.
Study ContactJennifer S Hill, BSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleClinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
NCT07008001
Principal SponsorSightGlass Vision, Inc.
Study ContactJennifer S Hill, BSMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

175 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Eye DiseasesMyopiaRefractive Errors

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single vision, impact-resistant spectacle lenses

Group II

Experimental
Single vision, impact-resistant spectacle lenses

Study 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

Recruiting

Aier Eye Hospital

Changsha, ChinaOpen Aier Eye Hospital in Google Maps
Recruiting

West China Hospital

Chengdu, China
Recruiting

Fudan University EENT

Shanghai, China
Recruiting

Tianjin Eye Hospital

Tianjin, China
Recruiting
5 Study Centers