Efficacy and Safety of Atropine and DIMS Lenses in Controlling Myopia in Children

Myopia Clinical Trial

— DIMS  

Official title:

Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431841
• Other study ID #: 21/522-EC_M
• Status: Recruiting
• Phase: Phase 4
• Start date: February 23, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Hospital San Carlos, Madrid
• Contact: Noemi Guemes, PHD
• Phone: 913303000
• Email: noemiguemes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0.025% atropine and DIMS spectacle lenses compared to 0.025% atropine and single vision (SV) lenses. Open-label, randomized, parallel clinical trial involving 50 subjects in each treatment arm (100 patients in total). The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction (SER) and axial length (AL) compared to baseline values.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

Inclusion criteria

• Age between 4-16 years.

• Signing of informed consent.

• Refractive error: myopia greater than -1.00 diopters (D).

• Myopia progression of at least -0.50 D in the last 12 months.

• Astigmatism of 2 D or less and anisometropia of 1.50 D or less.

• Best-corrected monocular visual acuity (VA) of 0.2 logMAR(6/9) or better.

Exclusion criteria

• Children under 4 years old and over 16 years old

• Strabismus and binocular vision anomalies.

• Alterations in eye fundus that the researcher consider necessary the patient exclution.

• Ocular pathology of the anterior segment (media opacity such as cataracts, glaucoma, aphakia, pseudophakia, uveitis, keratoconus or surface alterations), and any pathology of the posterior segment that prevents correct vision

• Amblyopia

• Previous eye surgery

• Systemic pathology (cardiopulmonary pathology, connective tissue alterations, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination to be carried out (such as mental or psychomotor retardation)

• Previous myopia control treatments including orthokeratology, rigid contact lenses, bifocal or myopia control soft contact lenses, bifocal and multifocal ophthalmic lenses within 3 months prior to the study.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine 0,025%
Atropine 0,025% (1 drop per day)

Device:
• DIMS Lenses
Use of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances.
• Monofocal lenses
Use of monofocal lenses.

Locations

Country	Name	City	State
Spain	Noemi Guemes	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic spherical equivalent refraction (SER) change	Cycloplegic spherical equivalent refraction (SER) change	2 years (24 months)
Primary	Axial length (AL) change	Axial length (AL) change	2 years (24 months)