Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control

NCT06431841 | Active Not Recruiting Phase 4

• 1 other identifier: 21/522-EC_M
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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 with 2 arms, involving 111 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Cycloplegic spherical equivalent refraction (SER) change

  Cycloplegic spherical equivalent refraction (SER) change

  2 years (24 months)

• Axial length (AL) change

  Axial length (AL) change

  2 years (24 months)

Study Arms (2)

DIMS Lenses

EXPERIMENTAL

Atropine 0,025% + DIMS Lenses

Drug: Atropine 0,025%; Device: DIMS Lenses

Monofocal Lenses

ACTIVE COMPARATOR

Atropine 0,025% + monofocal (single vision) Lenses

Drug: Atropine 0,025%; Device: Monofocal lenses

Interventions

Atropine 0,025% DRUG

Atropine 0,025% (1 drop per day)

DIMS Lenses; Monofocal Lenses

DIMS Lenses DEVICE

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.

DIMS Lenses

Monofocal lenses DEVICE

Use of monofocal lenses.

Monofocal Lenses

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Noemi Guemes

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and sponsor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: May 29, 2024
• Study Start: February 23, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)