Evaluation of the Efficacy in Decreasing Myopia Progression of the Proposed Ophthalmic Lens Prototypes

Indizen Optical Technologies

Status: Completed

Conditions: Myopia

Treatments: Other: Myopia control lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05250206

IOT-MIO-2018-01

Details and patient eligibility

About

Evaluation of the efficacy in decreasing myopia progression of the proposed ophthalmic lens prototypes.

Full description

A prospective, double-blind, randomized clinical trial (RCT) to analyze the effect of a new ophthalmic lens prototype on myopia progression. The follow-up period to evaluate the efficacy of the lens will be 3 years including a total of 5 visits.

The sample will consist of a group of 92 myopic children who will be randomly assigned to one of the treatment groups:

• Control group who will receive standard monofocal lenses.
• Treatment group who will wear a prototype lens based on peripheral positive defocus.

Enrollment: 92 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: 5 to 12 years old
• Myopia (spherical equivalent with cycloplegic) ≤ -0.50D
• Astigmatism < 1.50D
• Anisometropia < 1.50D
• Best-corrected visual acuity ≥ 20/20

Exclusion criteria

• Patients who have received any previous treatment for myopia control, including the use of RPG contact lenses.
• Participants with ocular pathology such as retinal detachment.
• Participants using drugs that may affect pupillary size and accommodation or that produce effects on the ocular surface.
• Participants with systemic diseases that may affect vision.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

Axial lenght increase

Experimental group

Description:

Children aged 5 to 12 with myopia up to -0.50 D, astigmatism and anisometropia under 1.50 D, and corrected visual acuity over 20/20 will be randomized to either the control group or treatment group. The myopia progression was evaluated by measuring axial length (AL) growth (IOL Master; Zeiss) over a period of one year.

Treatment:

Other: Myopia control lens