AELDA: Adverse Events Related to Low Dose Atropine
Study Details
Study Description
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 varying concentrations 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 using a questionnaire.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Eligibility: Myopic patients currently using 0.01%, 0.03%, or 0.05% 0.01% or 0.03% atropine eye drops, prescribed by the investigator(s).
At each visit, the investigator or study coordinator will begin by querying for adverse events by asking each patient a general, non-directed question 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 (5 years). Unless they choose to withdraw from the study.
The study will assess approximately 300 to 500 patients using 0.01%, 0.03%, or 0.05% atropine eye drops (prescribed by the investigator(s)), over a five-year period.
Study Design
Outcome Measures
Primary Outcome Measures
- Summary of adverse events [over 5 years]
Summary of adverse events by severity
- Summary of adverse events [over 5 years]
Summary of adverse events by duration
Secondary Outcome Measures
- Annual progression rate of myopia [over 5 years]
Annual progression rate of myopia determined by spherical equivalent from refraction
Other Outcome Measures
- Summary of Source of Atropine [over 5 years]
Summary of location of compounding pharmacy
Eligibility Criteria
Criteria
Inclusion Criteria:
Myopic patients currently using 0.01%, 0.03%, or 0.05% atropine eye drops, prescribed by the investigator.
Exclusion Criteria: None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laura Kirkeby | San Diego | California | United States | 92130 |
Sponsors and Collaborators
- Scripps Health
Investigators
- Principal Investigator: Gregory Ostrow, MD, Scripps Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.
- Fu A, Stapleton F, Wei L, Wang W, Zhao B, Watt K, Ji N, Lyu Y. Effect of low-dose atropine on myopia progression, pupil diameter and accommodative amplitude: low-dose atropine and myopia progression. Br J Ophthalmol. 2020 Nov;104(11):1535-1541. doi: 10.1136/bjophthalmol-2019-315440. Epub 2020 Feb 21.
- Gong Q, Janowski M, Luo M, Wei H, Chen B, Yang G, Liu L. Efficacy and Adverse Effects of Atropine in Childhood Myopia: A Meta-analysis. JAMA Ophthalmol. 2017 Jun 1;135(6):624-630. doi: 10.1001/jamaophthalmol.2017.1091.
- 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.
- Pineles SL, Kraker RT, VanderVeen DK, Hutchinson AK, Galvin JA, Wilson LB, Lambert SR. Atropine for the Prevention of Myopia Progression in Children: A Report by the American Academy of Ophthalmology. Ophthalmology. 2017 Dec;124(12):1857-1866. doi: 10.1016/j.ophtha.2017.05.032. Epub 2017 Jun 29.
- Yam JC, Jiang Y, Tang SM, Law AKP, Chan JJ, Wong E, Ko ST, Young AL, Tham CC, Chen LJ, Pang CP. Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019 Jan;126(1):113-124. doi: 10.1016/j.ophtha.2018.05.029. Epub 2018 Jul 6.
- AELDA