The Influence of Atropine on Choroidal Thickness
Primary Purpose
Myopia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atropine Sulfate 1% Oph Soln
Sponsored by
About this trial
This is an interventional basic science trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- Good general and ocular health
- Soft contact lens wearers to cease lens wear for at least 24 hours
- No previous rigid gas permeable lens wear
Exclusion Criteria:
- History of ocular surgery, including refractive surgery
- Amblyopia
- Use of ocular medications
- Known allergies or sensitivity to atropine
- Pregnant, plan to become pregnant, or are breastfeeding
- Taking monoamine oxidase inhibitors (MAOIs)
Sites / Locations
- State University of New York College of Optometry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Atropine group
Arm Description
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
Outcomes
Primary Outcome Measures
Choroidal thickness
Change in choroidal thickness after atropine
Secondary Outcome Measures
Full Information
NCT ID
NCT03158142
First Posted
May 16, 2017
Last Updated
October 10, 2018
Sponsor
State University of New York College of Optometry
Collaborators
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT03158142
Brief Title
The Influence of Atropine on Choroidal Thickness
Official Title
The Influence of Atropine on Choroidal Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State University of New York College of Optometry
Collaborators
The University of New South Wales
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
Detailed Description
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:
Determine the effect of am or pm atropine application on choroid thickness
Determine the effect of atropine on choroid thickness in relationship to baseline thickness
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atropine group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Atropine Sulfate 1% Oph Soln
Other Intervention Name(s)
1% atropine eye drops
Intervention Description
Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic
Primary Outcome Measure Information:
Title
Choroidal thickness
Description
Change in choroidal thickness after atropine
Time Frame
Baseline, then after approximately 1, 12, 24 and 96 hours after atropine instillation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good general and ocular health
Soft contact lens wearers to cease lens wear for at least 24 hours
No previous rigid gas permeable lens wear
Exclusion Criteria:
History of ocular surgery, including refractive surgery
Amblyopia
Use of ocular medications
Known allergies or sensitivity to atropine
Pregnant, plan to become pregnant, or are breastfeeding
Taking monoamine oxidase inhibitors (MAOIs)
Facility Information:
Facility Name
State University of New York College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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
Learn more about this trial
The Influence of Atropine on Choroidal Thickness
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