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ACTIVE NOT RECRUITING
NCT06431841
PHASE4

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

Sponsor: Hospital San Carlos, Madrid

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

4 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2022-02-23

Completion Date

2026-06-30

Last Updated

2025-09-11

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

Noemi Guemes

Madrid, Madrid, Spain