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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine 0,025%; Device: DIMS Lenses; Device: Monofocal lenses

• Study Type: Interventional
• Enrollment (Estimated): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Madrid, Madrid, Spain, 28040
      • Noemi Guemes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DIMS Lenses; Atropine 0,025% + DIMS Lenses	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.
Active Comparator: Monofocal Lenses; Atropine 0,025% + monofocal (single vision) Lenses	Drug: Atropine 0,025%; Atropine 0,025% (1 drop per day); Device: Monofocal lenses; Use of monofocal lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Atropine
• Other Study ID Numbers: 21/522-EC_M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No