Atropine and Spectacle Combination Treatment (ASPECT): 12-month Results of a Randomized Clinical Trial for Myopia Control
Phase 4
Active, not recruiting
- Conditions
- Myopia
- Interventions
- Registration Number
- NCT06431841
- Lead Sponsor
- Hospital San Carlos, Madrid
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DIMS Lenses Atropine 0,025% Atropine 0,025% + DIMS Lenses DIMS Lenses DIMS Lenses Atropine 0,025% + DIMS Lenses Monofocal Lenses Atropine 0,025% Atropine 0,025% + monofocal (single vision) Lenses Monofocal Lenses Monofocal lenses Atropine 0,025% + monofocal (single vision) Lenses
- Primary Outcome Measures
Name Time Method Cycloplegic spherical equivalent refraction (SER) change 2 years (24 months) Cycloplegic spherical equivalent refraction (SER) change
Axial length (AL) change 2 years (24 months) Axial length (AL) change
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Noemi Guemes
🇪🇸Madrid, Spain