Efficacy and Tolerance of Full Field Peripheral Defocus Spectacles for the Control of Myopia Progression (Myofix Study)

NCT07092072 | Completed DMC

• 2 other identifiers: Registration No. 8638/23Registration No. 8638
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of the use of a new model of spectacles designed to control the progression of myopia in childhood. School myopia in children is mainly produced by increased ocular growth. This new spectacle design is based in the fact that positive lenses in front of eyes produce changes that decrease ocular growth. It consists of a full field peripheral positive defocus lens and a central section for the distance correction. The study is designed to evaluate tolerance and efficacy of this new lens in myopic children along a two year period.

Conditions

Myopia Progression

Keywords

Myopia control spectacles, full field defocus design

Outcome Measures

Primary Outcomes (1)

• RATE OF MYOPIA PROGRESSION IN DIOPTERS

  THE AMOUNT OF DIOPTERS OF MYOPIC PROGRESSION IN ONE YEAR FOLLOW UP MEASURED WITH CYCLOPLEGIC REFRACTIONS

  12 MONTHS AND 24 MONTHS FOLLOW UP PLANNED

Study Arms (1)

MYOPIA TREATED

EXPERIMENTAL

MYOPIC CHILDREN TREATED WITH MYOFIX SPECTACLES

Device: MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE

Interventions

MYOFIX FULL FIELD PERIPHERAL DEFOCUS SPECTACLE DEVICE

This is a plus peripheral add spectacle with the central part for the myopic correction.

MYOPIA TREATED

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7 to 16 years who voluntarily agreed to use the Defocus spectacles for one year.
• A consecutive series of children diagnosed with myopia, attending accredited private practice ophthalmology clinics across Argentina.
• Absence of ocular pathology other than myopia,
• Spherical equivalent (SE = sphere + \[cylinder/2\]) between ≤-0.50 D and -5.00 D
• Astigmatism less than -2.00 D
• Anisometropia less than -1.00 D
• Keratometry less than 47.00 D in the steepest meridian
• The corrected distance visual acuity based on subjective refraction was required to be 0.1 logMAR (20/25 Feet Snellen) or better in each eye.

You may not qualify if:

• Myopia with onset before the age of 6 years,
• Any genetic syndromes,
• Current medical treatment for myopia other than single vision spectacle correction.

Sponsors & Collaborators

• Novar Corporation: lead

Study Sites (1)

Drs. Iribarren Eye Consultants

Buenos Aires, 1061, Argentina

Location

Related Publications (6)

• De Tomas M, Kotlik C, Szeps A, Impagliazzo R, Iribarren R. New Spectacles for Myopia Control. Oftalmol Clin Exp. 2022; 15: 240-7.

  BACKGROUND

• Iribarren R SA, Kotlik C, Laurencio L, De Tomas M, Impagliazzo R, Martin G. Short-Term Axial Length Changes in Myopic Eyes Induced by Defocus Spectacles for Myopia Control. Photonics 2023; 10: 668.

  BACKGROUND

• De Tomás M SA, Martín G, Saracco G, Lanca C, Iribarren R. Effect of vertex distance in the treatment area of myopia control spectacles. Oftalmol Clin Exp 2024; 17: e547-e53.

  BACKGROUND

• Saracco G AM, De Tomás M, Martín G, Iribarren R. Development of a frame adaptation for myopia control spectacles. Oftalmol Clin Exp 2025; 18: e195-e201.

  BACKGROUND

• Szeps A KC, Fernández Irigaray L, Saracco G, De Tomas M, Martin G, Iribarren R. Baseline data in the study on the tolerance and efficacy of peripheral defocus spectacles for the control of myopia progression in Argentina (Myofix Defocus Study). Oftalmol Clin Exp 2024; 17: 352-8.

  RESULT

• Iribarren R, Szeps A, Kotlik C, de Tomas M, Martin G, Rozema J, Lanca C. One-Year Efficacy and Tolerance of Myofix Defocus Spectacles for Control of Myopia Progression. Ophthalmol Ther. 2025 Nov 12. doi: 10.1007/s40123-025-01270-4. Online ahead of print.

  PMID: 41222872 DERIVED

Study Design

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

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 29, 2025
• Study Start: May 23, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD and supporting information will be available after the study is finished and published with no time limit.
• Access Criteria: Any researcher in myopia control area may ask for the data. The data will be provided in an SSPS dataset, send at their formal request.

Locations

AR (1)