Adverse Events Related to Low Dose Atropine (AELDA)

April 21, 2023 updated by: Scripps Health

Adverse Events Questionnaire for Low Dose Atropine Eye Drops

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92130
        • Laura Kirkeby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients diagnosed with myopia and using either 0.01%, 0.03%, or 0.05% atropine eye drops daily, prescribed by the principal investigator.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of adverse events by dose level at the time of the adverse event
Time Frame: up to 5 years
Summary of total adverse events and severity of adverse events, by dose level at time of the adverse event
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual progression rate of myopia
Time Frame: over 5 years
Annual progression rate of myopia determined by spherical equivalent from refraction
over 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of Source of Atropine
Time Frame: up to 5 years
Summary of name of compounding pharmacy, cost of eye drops, size of the bottle of eye drops, and if there was a delay in obtaining eye drops from the compounding pharmacy.
up to 5 years
Summary of adverse events by starting dose
Time Frame: up to 5 years
Summary of adverse events by dose of atropine prescribed at start of study
up to 5 years
Summary of demographics and medical history by atropine starting dose
Time Frame: up to 5 years
Summary of demographics and medical history by atropine starting dose
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Investigators

  • Principal Investigator: Gregory Ostrow, MD, Scripps Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

January 9, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AELDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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