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

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.

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.