Clinical trial

Effect of Low Concentration Atropine Eye Drops on Choroidal Thickness, Central Corneal Thickness, Anterior Scleral Thickness and Axial Length in Myopic Children

Name

LDAED IN MC

Description

Previous Studies reported that low concentration atropine eye drops may be effective in increasing the choroidal blood flow and thickness and this slows myopia progression. purpose of the study is to compare changes in axial length, anterior chamber depth, choroidal thickness, central corneal thickness and anterior scleral thickness among myopic children receiving atropine 0.05% or 0.01% and placebo.

Trial arms

Trial start

2024-09-01

Estimated PCD

2025-12-30

Trial end

2026-03-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

low dose atropine eye drops

Atropine is a nonselective muscarinic antagonist used for myopia control in previous studies.

Arms:

myopic children atropine 0.01%, myopic children atropine 0.05%

Placebo

placebo

Arms:

myopic children placebo

Size

Primary endpoint

change in the average Choroidal Thickness over follow up period.

from enrollment till end of eye drops trial over 3 months and after stopping the drops for 3 months

Eligibility criteria

Inclusion Criteria: * Age ranges from 6 to 12. * Spherical equivalent ≥ -1.0 D. Exclusion Criteria: * Astigmatism ≥ 3.0 D. * History of allergy to atropine or positive skin allergy test. * Ocular pathology otherwise myopia. * Recent ocular surgery. * Chronic systemic disease. * Use of rigid contact lenses or soft contact lenses for 1 week before participating in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}

Updated at

2024-02-20

1 organization

1 product

1 drug

4 indications

Organization

Ain Shams University

Product

Atropine Eye Drops

Indication

Myopia