Assessment of DOT Spectacles in Chinese Children (CATHAY)

SightGlass Vision

Status: Active, not recruiting

Conditions: Myopia; Juvenile Myopia

Treatments: Device: Spectacle lenses; Device: Novel spectacle lens design

Study type: Interventional

Funder types: Industry

Identifiers

NCT05562622

CPRO-2201-001

Details and patient eligibility

About

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.

Enrollment: 195 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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195 participants in 2 patient groups

SightGlass Vision Test Arm 1

Experimental group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Novel spectacle lens design

Test Arm 2

Other group

Description:

Single vision, impact-resistant spectacle lenses

Treatment:

Device: Spectacle lenses