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

San Carlos Clinical Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Myopia

Treatments: Device: Monofocal lenses; Drug: Atropine 0,025%; Device: DIMS Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT06431841

21/522-EC_M

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

DIMS Lenses

Experimental group

Description:

Atropine 0,025% + DIMS Lenses

Treatment:

Device: DIMS Lenses

Drug: Atropine 0,025%

Monofocal Lenses

Active Comparator group

Description:

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

Treatment:

Device: Monofocal lenses

Drug: Atropine 0,025%