search
Back to results

Assessment of DOT Spectacles in Chinese Children (CATHAY)

Primary Purpose

Juvenile Myopia, Myopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Novel spectacle lens design
Spectacle lenses
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Myopia

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aier Eye HospitalRecruiting
  • West China HospitalRecruiting
  • Zhongshan Ophthalmic Center
  • Fudan University EENTRecruiting
  • Tianjin Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SightGlass Vision Test Arm 1

Test Arm 2

Arm Description

Single vision, impact-resistant spectacle lenses

Single vision, impact-resistant spectacle lenses

Outcomes

Primary Outcome Measures

Axial length
Change in axial length from baseline

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
April 10, 2023
Sponsor
SightGlass Vision, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05562622
Brief Title
Assessment of DOT Spectacles in Chinese Children
Acronym
CATHAY
Official Title
Clinical Assessment of DOT Spectacle Lenses in Chinese Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2023 (Actual)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Myopia, Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SightGlass Vision Test Arm 1
Arm Type
Experimental
Arm Description
Single vision, impact-resistant spectacle lenses
Arm Title
Test Arm 2
Arm Type
Other
Arm Description
Single vision, impact-resistant spectacle lenses
Intervention Type
Device
Intervention Name(s)
Novel spectacle lens design
Intervention Description
Use of lenses may reduce the rate of progression of juvenile myopia
Intervention Type
Device
Intervention Name(s)
Spectacle lenses
Intervention Description
Use of lenses may reduce the rate of progression of juvenile myopia
Primary Outcome Measure Information:
Title
Axial length
Description
Change in axial length from baseline
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children 6-13 years of age SER error between -0.75D and -5.00D Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear Exclusion Criteria: Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K) Astigmatism worse than -1.50 DC (by manifest refraction) in either eye Anisometropia (SER manifest refraction) greater than 1.00 D
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer S Hill, BS
Phone
678-361-4877
Email
jhill@sightglassvision.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Tasso, MA, MBA
Phone
949-751-7039
Email
vtasso@sightglassvision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Richdale, OD, PhD
Organizational Affiliation
SightGlass Vision
Official's Role
Study Director
Facility Information:
Facility Name
Aier Eye Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoning Li
First Name & Middle Initial & Last Name & Degree
Xiaoning Li
Facility Name
West China Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Longqian Liu
First Name & Middle Initial & Last Name & Degree
Longqian Liu
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Yang
First Name & Middle Initial & Last Name & Degree
Xiao Yang
Facility Name
Fudan University EENT
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Chen
First Name & Middle Initial & Last Name & Degree
Peter Chen
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Li
First Name & Middle Initial & Last Name & Degree
Lihua Li

12. IPD Sharing Statement

Learn more about this trial

Assessment of DOT Spectacles in Chinese Children

We'll reach out to this number within 24 hrs