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OpenTrials
Completed

NCT Number: NCT05683535

Adverse Events Related to Low Dose Atropine

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Laura Kirkeby

San Diego, California, 92130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atropine Sulfate

Drug

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

Primary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Official study title

Adverse Events Questionnaire for Low Dose Atropine Eye Drops

Acronym: AELDA

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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