Overview

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

Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Hospital San Carlos, Madrid