Clinical trial

Adverse Events Questionnaire for Low Dose Atropine Eye Drops

Name

AELDA

Description

Progressive myopia can lead to severe vision loss and is associated with retinal detachment, glaucoma, and other comorbidities. Several studies have shown that off-label, low-dose atropine eye drops slow the progression of myopia. Many eye care providers are now prescribing off-label atropine eye drops for their myopic patients, with the prescribed concentrations varying amongst providers. The purpose of this study is to determine if low-dose atropine eyedrops used daily, cause adverse effects to the eyes. Patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops obtained from compounding pharmacies will be assessed for associated adverse effects.

Trial arms

Trial start

2018-06-19

Estimated PCD

2023-01-09

Trial end

2023-01-09

Status

Completed

Treatment

Atropine Sulfate

0.01%, 0.03%, or 0.05% atropine eye drops made from compounding pharmacies.

Size

148

Primary endpoint

Summary of adverse events by dose level at the time of the adverse event

up to 5 years

Eligibility criteria

Inclusion Criteria: * patients diagnosed with myopia * patients must be currently using 0.01%, 0.03%, or 0.05% atropine eye drops daily * low-dose atropine eye drops must be prescribed by the principal investigator and obtained from a compounding pharmacy Exclusion Criteria: * patients without myopia * patients with myopia, but not using low-dose atropine eye drops

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 148, 'type': 'ACTUAL'}}

Updated at

2023-04-25

1 organization

1 product

2 indications

Organization

Product

Indication

Indication