Adverse Events Related to Low Dose Atropine

Completed

• Conditions: Myopia, Progressive

• Registration Number: NCT05683535
• Lead Sponsor: Scripps Health

Brief Summary

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.

Detailed Description

Eligibility: Myopic patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops, prescribed by the investigator(s).

Patients that meet the eligibility criteria will be given the parental consent form and child assent form (if applicable) during their regularly scheduled office visit. After consent forms are signed and at each follow-up visit, the investigator or study coordinator will begin by querying for adverse events by asking each patient general, non-directed questions, such as "How have you been feeling since the last visit?" Directed questioning and examination will then be done as appropriate. All reported adverse events will be documented on the appropriate CRF. The patients will then continue with their regular eye exam.

Patients enrolled in the study will be assessed for adverse events at each regularly scheduled office visit for the duration of the study (up to 5 years), unless they choose to withdraw from the study.

The study will assess 148 patients using either 0.01%, 0.03%, or 0.05% atropine eye drops (prescribed by the investigator), over a five-year period.

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-04
• Primary Completion: 2023-01-09
• Study Completion: 2023-01-09
• Study First Posted: 2023-01-13
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Summary of adverse events by dose level at the time of the adverse event	up to 5 years	Summary of total adverse events and severity of adverse events, by dose level at time of the adverse event

Trial Locations

Locations (1)

Laura Kirkeby; 🇺🇸 San Diego, California, United States