Assessment of DOT Spectacles in Chinese Children (CATHAY)

April 29, 2026 updated by: SightGlass Vision, Inc.

Clinical Assessment of DOT Spectacle Lenses in Chinese Children

This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Aier Eye Hospital
      • Chengdu, China
        • West China Hospital
      • Guangzhou, China
        • Zhongshan Ophthalmic Center
      • Shanghai, China
        • Fudan University EENT
      • Tianjin, China
        • Tianjin Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Children 6-13 years of age
  2. SER error between -0.75D and -5.00D
  3. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear

Exclusion Criteria:

  1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
  2. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
  3. Anisometropia (SER manifest refraction) greater than 1.00 D

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SightGlass Vision Test Arm 1
Single vision, impact-resistant spectacle lenses
Device: Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
Other: Test Arm 2
Single vision, impact-resistant spectacle lenses
Device: Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 12 months
Change in axial length from baseline
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SightGlass Vision, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPRO-2201-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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