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

Study acronym: ASPECT
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study completion date: Dec 31, 2025 to Jun 30, 2026v5
  2. Enrollment target: 100 to 111v4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Study title expanded, about 3 words
    v3
  4. Interventions: Atropine 0,025% + DIMS/monofocal Lenses (Drug) to Atropine 0,025% (Drug), DIMS Lenses (Device), Monofocal lenses (Device)
    • Study title shortened, about 4 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06431841
Lead Sponsor Hospital San Carlos, Madrid
Conditions
(from sponsor)		 Myopia
Related terms Myopia
Enrollment 111 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov