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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT05250206
• Lead Sponsor: Indizen Optical Technologies, S.L.U.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-06-07
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-22
• Results First Submitted: 2023-12-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Results First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Results First Posted: 2025-06-10
• Last Update Posted: 2025-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Axial Lenght Increase	5 minutes	Axial length was measured with the IOL Master® optical biometer (Carl Zeiss Meditec, Jena, Germany) and axial length growth was calculated by subtracting the axial length measurement after one year of treatment and the axial length at the initial visit.

Trial Locations

Locations (1)

Universidad Europea of Madrid; 🇪🇸 Madrid, Spain