A Phase 4 interventional study of Atropine Sulfate 1% Oph Soln in Myopia, sponsored by State University of New York College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by State University of New York College of Optometry · Phase 4, Interventional, and Basic science
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects.
The aim of this study is to characterize the effects of atropine on choroidal thickness and the influence of time of administration (am vs pm). It is hypothesized that the atropine's effect on choroidal thickness will vary with baseline thickness related to diurnal rhythm, where thicker baseline thickness will show a reduced choroidal response.
Atropine eye drops are increasingly prescribed for the management of progressive myopia or short-sightedness. A previous study suggested that the back of the eye or choroid may be a part of the mechanism by which it induces its effects. The choroid shows diurnal variation and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown. Thus, the objective of this study is to provide data to characterize the influence of atropine on choroid thickness. The study aims are to:
Participants will be asked to attend a screening session and 13 study visits. Following the screening visit, participants will be scheduled to return for 4 visits across 12 hours (4 hour intervals starting from 8am) in a single day where eye shape measurements will be taken to characterize diurnal variations in eye shape.
Subjects will then be randomized to receive a drop of 1% atropine eye drops in both eyes in the morning or a night. Measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation. After a 2 week washout period, 1% atropine eye drops will be administered either in the morning or at night (the visit that was not previously scheduled) and measurements of the shape of the front and back of the eye will be taken after approximately 1, 12, 24 and 96 hours after drop instillation.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 783 interventional studies indexed under Myopia.
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Exclusion Criteria:
One drop of Atropine Sulfate 1% Oph Soln will be administered either in the morning or at night in each eye. Study measurements will be taken approximately after 1, 12, 24 and 96 hours after drop instillation. After a 2 week wash out period with no eye drops, another drop of 1% atropine sulfate ophthalmic eye drops will be administered either in the morning or night (the visit that was not taken before) and study measurements will be scheduled approximately after 1, 12 24 and 96 hours after drop instillation
Drug: Atropine Sulfate 1% Oph Soln
Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic
Also known as: 1% atropine eye drops
Choroidal thickness
Change in choroidal thickness after atropine
Time frame: Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation
Plan to share: No — All IPD collected from the study will be made available to other the investigators that have been listed on this study. IPD will be de-identified before making it available to the other investigators. IPD will become available after the end of study data collection. Deidentified IPD will be obtained by other investigator in excel files sent by the primary investigator
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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State University of New York College of Optometry