Myopia, Progressive
Conditions
Keywords
adverse events, nearsightedness, atropine
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.
Interventions
DRUGAtropine Sulfate
0.01%, 0.03%, or 0.05% atropine eye drops made from compounding pharmacies.
Sponsors
Scripps Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Source of Atropine | 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. |
| Summary of adverse events by starting dose | up to 5 years | Summary of adverse events by dose of atropine prescribed at start of study |
| Summary of demographics and medical history by atropine starting dose | up to 5 years | Summary of demographics and medical history by atropine starting dose |
Countries
United States
Outcome results
None listed