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

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514651-15-00

Acronym

01-DIMS-2021

Enrollment

111

Registered

2024-07-18

Start date

2022-02-16

Completion date

Unknown

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

Change in refractive error after cycloplegia (with 1% cyclopentolate 3 drops 10 minutes apart; measured after 30 minutes) relative to baseline values., Proportion of patients presenting adverse events

Detailed description

Change in axial length in millimetres, relative to baseline values, Change in choroidal and retinal thickness measured on Optical Coherence Tomography (OCT) in μm, relative to baseline values, Change in intraocular pressure in mmHg, relative to baseline values

Interventions

DRUGATROPINE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

Measure	Time frame
Change in axial length in millimetres, relative to baseline values, Change in choroidal and retinal thickness measured on Optical Coherence Tomography (OCT) in μm, relative to baseline values, Change in intraocular pressure in mmHg, relative to baseline values	—

Primary

Measure	Time frame
Change in refractive error after cycloplegia (with 1% cyclopentolate 3 drops 10 minutes apart; measured after 30 minutes) relative to baseline values., Proportion of patients presenting adverse events	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026