NCT06431841

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

Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DRUG	Atropine 0,025%	Atropine 0,025% (1 drop per day)
DEVICE	DIMS Lenses	Use of peripheral defocus lenses with DIMS technology, the design of which simultaneously introduces myopic defocus and provides clear vision to the wearer at all viewing distances.
DEVICE	Monofocal lenses	Use of monofocal lenses.

Timeline

• Start date: 2022-02-23
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2024-05-29
• Last updated: 2025-09-11

Locations

1 site across 1 country: Spain