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

NCT05250206 | Completed Results DMC

• 1 other identifier: IOT-MIO-2018-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Axial Lenght Increase

  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.

  5 minutes

Study Arms (1)

Axial lenght increase

EXPERIMENTAL

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.

Other: Myopia control lens

Interventions

Myopia control lens OTHER

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

Axial lenght increase

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indizen Optical Technologies, S.L.U.: lead
• Universidad Europea de Madrid: collaborator

Study Sites (1)

Universidad Europea of Madrid

Madrid, 28670, Spain

Location

Related Publications (3)

• Hasebe S, Jun J, Varnas SR. Myopia control with positively aspherized progressive addition lenses: a 2-year, multicenter, randomized, controlled trial. Invest Ophthalmol Vis Sci. 2014 Sep 30;55(11):7177-88. doi: 10.1167/iovs.12-11462.

  PMID: 25270192 BACKGROUND

• Kanda H, Oshika T, Hiraoka T, Hasebe S, Ohno-Matsui K, Ishiko S, Hieda O, Torii H, Varnas SR, Fujikado T. Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial. Jpn J Ophthalmol. 2018 Sep;62(5):537-543. doi: 10.1007/s10384-018-0616-3. Epub 2018 Aug 6.

  PMID: 30083910 BACKGROUND

• Morgan IG, Ohno-Matsui K, Saw SM. Myopia. Lancet. 2012 May 5;379(9827):1739-48. doi: 10.1016/S0140-6736(12)60272-4.

  PMID: 22559900 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Indizen Optical Technologies (Madrid), Universidad Complutense de Madrid

evachamorro@iot.es

+34 (91) 833 37 86

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 22, 2022
• Study Start: June 7, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)