Myopia Control Efficacy of Second-generation DIMS Spectacle Lenses on Fast Progressing Myopes - Auxiliary Group

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Myopia

Treatments: Other: DIMS spectacle lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05888805

P0043588

Details and patient eligibility

About

The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Full description

DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time.

Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Enrollment: 59 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• SER: -1.00D or below
• Documented history of fast progressing myopia, either in SER or AL
• SER progression: 0.50D/year or more
• AL elongation: 0.27mm/year or more
• Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better
• Acceptance of random group allocation and the masked study design
• Anisometropia of 1.50 D or less
• Astigmatism of 2.00 D or less

Exclusion criteria

• Strabismus and binocular vision abnormalities
• Ocular and systemic abnormalities
• Prior experience of myopia control

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

DIMS lens group

Other group

Description:

Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.

Treatment:

Other: DIMS spectacle lens