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

Last updated: October 28, 2024
Sponsor: Hospital San Carlos, Madrid
Overall Status: Active - Not Recruiting

Phase

4

Condition

Myopia

Treatment

Atropine 0,025% + DIMS/monofocal Lenses

Monofocal lenses

DIMS Lenses

Clinical Study ID

NCT06431841
21/522-EC_M
  • Ages 4-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 111
Treatment Group(s): 4
Primary Treatment: Atropine 0,025% + DIMS/monofocal Lenses
Phase: 4
Study Start date:
February 23, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Noemi Guemes

    Madrid, 28040
    Spain

    Site Not Available

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