Clinical Trial

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

Study acronym: ASPECT
Active, Not Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-05-21; most recent amendment 2025-09-10.
Status change: Recruiting → Active, Not Recruiting 2024-10-22
Trial Details
NCT Number NCT06431841
Lead Sponsor Hospital San Carlos, Madrid
Conditions Myopia
Enrollment 111 participants
Start Date 2022-02-23
Primary Completion 2025-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-11