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CATHAY: Assessment of DOT Spectacles in Chinese Children

Sponsor
SightGlass Vision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05562622
Collaborator
(none)
200
Enrollment
5
Locations
2
Arms
13.7
Anticipated Duration (Months)
40
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Novel spectacle lens design
  • Device: Spectacle lenses
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Primary Purpose:
Treatment
Official Title:
Clinical Assessment of DOT Spectacle Lenses in Chinese Children
Anticipated Study Start Date :
Dec 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Axial length [12 months]

    Change in axial length from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aier Eye Hospital Changsha China
2 West China Hospital Chengdu China
3 Zhongshan Ophthalmic Center Guangzhou China
4 Fudan University EENT Shanghai China
5 Tianjin Eye Hospital Tianjin China

Sponsors and Collaborators

  • SightGlass Vision, Inc.

Investigators

  • Study Director: Kathryn Richdale, OD, PhD, SightGlass Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SightGlass Vision, Inc.
ClinicalTrials.gov Identifier:
NCT05562622
Other Study ID Numbers:
  • CPRO-2201-001
First Posted:
Oct 3, 2022
Last Update Posted:
Nov 2, 2022
Last Verified:
Sep 1, 2022
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
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Nov 2, 2022