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

NCT ID: NCT06431841

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DIMS Lenses

Atropine 0,025% + DIMS Lenses

Group Type: EXPERIMENTAL

Atropine 0,025%

Intervention Type: DRUG

Atropine 0,025% (1 drop per day)

DIMS Lenses

Intervention Type: 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.

Monofocal Lenses

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

Group Type: ACTIVE_COMPARATOR

Atropine 0,025%

Intervention Type: DRUG

Atropine 0,025% (1 drop per day)

Monofocal lenses

Intervention Type: DEVICE

Use of monofocal lenses.

Interventions

Atropine 0,025%

Atropine 0,025% (1 drop per day)

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Monofocal lenses

Use of monofocal lenses.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Noemi Guemes

Principal Investigator and sponsor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Noemi Guemes

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

21/522-EC_M

Identifier Type: -

Identifier Source: org_study_id