Clinical trial NCT05683535: Adverse Events Related to Low Dose Atropine
Official title: Adverse Events Questionnaire for Low Dose Atropine Eye Drops
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia, Progressive
Keywords: adverse events
nearsightedness
atropine
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Summary of adverse events by dose level at the time of the adverse event
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
measure: Summary of Source of Atropine
timeFrame: up to 5 years
measure: Summary of adverse events by starting dose
timeFrame: up to 5 years
measure: Summary of demographics and medical history by atropine starting dose
timeFrame: up to 5 years
Locations:
city: San Diego
country: United States
facility: Laura Kirkeby
state: California
Study officials:
affiliation: Scripps Health
name: Gregory Ostrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leo SW; Scientific Bureau of World Society of Paediatric Ophthalmology and Strabismus (WSPOS). Current approaches to myopia control. Curr Opin Ophthalmol. 2017 May;28(3):267-275. doi: 10.1097/ICU.0000000000000367.
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