Assessment of DOT Spectacles in Chinese Children

NCT ID: NCT05562622

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-05

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Myopia Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked.

Study Groups

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SightGlass Vision Test Arm 1

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

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

Test Arm 2

Single vision, impact-resistant spectacle lenses

Group Type OTHER

Spectacle lenses

Intervention Type DEVICE

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

Interventions

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Novel spectacle lens design

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

Intervention Type DEVICE

Spectacle lenses

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SightGlass Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aier Eye Hospital

Changsha, , China

Site Status

West China Hospital

Chengdu, , China

Site Status

Zhongshan Ophthalmic Center

Guangzhou, , China

Site Status

Fudan University EENT

Shanghai, , China

Site Status

Tianjin Eye Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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CPRO-2201-001

Identifier Type: -

Identifier Source: org_study_id