Assessment of DOT Spectacles in Chinese Children Extension

NCT ID: NCT07008001

Last Updated: 2025-12-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-31

Brief Summary

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This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) 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 to participant's former treatment group.

Study Groups

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SightGlass Vision Test Arm Groups I (formerly test group)

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

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

SightGlass Vision Test Arm Groups II (formerly control group)

Single vision, impact-resistant spectacle lenses

Group Type EXPERIMENTAL

Novel spectacle lens design

Intervention Type DEVICE

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

Interventions

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Novel spectacle lens design

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Previously a successfully completed participant in the CATHAY study (NCT05562622)
2. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day)
3. Willingness to participate in the trial for 12 months without contact lens wear or any other myopia management intervention
4. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form

Exclusion Criteria

1\. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 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 RECRUITING

West China Hospital

Chengdu, , China

Site Status RECRUITING

Zhongshan Ophthalmic Center

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Fudan University EENT

Shanghai, , China

Site Status RECRUITING

Tianjin Eye Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jennifer S Hill, BS

Role: CONTACT

Phone: 678-361-4877

Email: [email protected]

Vanessa Tasso, MA, MBA

Role: CONTACT

Phone: 949-751-7039

Email: [email protected]

Facility Contacts

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Xiaoning Li

Role: primary

Longqian Liu

Role: primary

Xiao Yang

Role: primary

Peter Chen

Role: primary

Lihua Li

Role: primary

Other Identifiers

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CPRO-2201-002

Identifier Type: -

Identifier Source: org_study_id