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ACTIVE NOT RECRUITING
NCT05886348
NA

The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens

Sponsor: HOYA Lens Thailand LTD.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test Novel spectacle lenses in myopic children. The main question it aims to answer are: safety and efficacy of the lenses. Participants will be asked to wear spectacles and participate in eye exams and questionnaires. Researchers will compare Novel spectacle lenses and general single vision spectacle lenses to see if the Novel spectacle lenses correct myopic ametropia, slow the progression of myopia and axial elongation.

Key Details

Gender

All

Age Range

7 Years - 13 Years

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2023-07-31

Completion Date

2027-05-31

Last Updated

2026-03-23

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Model-A Novel spectacle lens

Model-A Novel spectacle lenses will be given to 1 arm to wear for 36 months

DEVICE

Model-B Novel spectacle lens

Model-B Novel spectacle lenses will be given to 1 arm to wear for 36 months

DEVICE

Single vision spectacle lens

Single Vision Spectacle lenses will be given to 1 arm to wear for 36 months

Locations (5)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Guangzhou Aier Eye Hospital

Guangzhou, China

Eye and ENT Hospital of Fudan University

Shanghai, China

Shengyang He Eye Specialist Hospital

Shengyang, China

Tianjin Medical University Eye Hospital

Tianjin, China