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NCT Number: NCT06431841

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Noemi Guemes

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atropine 0,025%

Drug

Atropine 0,025% (1 drop per day)

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.

Monofocal lenses

Device

Use of monofocal lenses.

Primary outcomes

  1. Cycloplegic spherical equivalent refraction (SER) change

    Time frame: 2 years (24 months)

    Cycloplegic spherical equivalent refraction (SER) change

  2. Axial length (AL) change

    Time frame: 2 years (24 months)

    Axial length (AL) change

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study 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.

Acronym: ASPECT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 29, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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