NCT05562622

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2023Dec 2027

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 5, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

September 28, 2022

Last Update Submit

April 29, 2026

Conditions

Juvenile MyopiaMyopia

Outcome Measures

Primary Outcomes (1)

  • Axial length

    Change in axial length from baseline

    12 months

Study Arms (2)

SightGlass Vision Test Arm 1

EXPERIMENTAL

Single vision, impact-resistant spectacle lenses

Device: Novel spectacle lens design

Test Arm 2

OTHER

Single vision, impact-resistant spectacle lenses

Device: Spectacle lenses

Interventions

Novel spectacle lens designDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

SightGlass Vision Test Arm 1
Spectacle lensesDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Test Arm 2

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Aier Eye Hospital

Changsha, China

Location

West China Hospital

Chengdu, China

Location

Zhongshan Ophthalmic Center

Guangzhou, China

Location

Fudan University EENT

Shanghai, China

Location

Tianjin Eye Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

February 5, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

CN(5)