Assessment of DOT Spectacles in Chinese Children Extension (CATHAY Ext)

SightGlass Vision

Status: Enrolling

Conditions: Myopia; Juvenile Myopia

Treatments: Device: Novel spectacle lens design

Study type: Interventional

Funder types: Industry

Identifiers

NCT07008001

CPRO-2201-002

Details and patient eligibility

About

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.

Enrollment: 175 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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175 participants in 2 patient groups

SightGlass Vision Test Arm Groups I (formerly test group)

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design

SightGlass Vision Test Arm Groups II (formerly control group)

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design