Side Effects of Atropine (SEA) Study (SEA)
Primary Purpose
Myopia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
0.01% concentration atropine drops
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring atropine, photophobia, pupil, reading speed, myopia, Surveys and Questionnaires
Eligibility Criteria
Inclusion Criteria:
-N/A
Exclusion Criteria:
- Outside of age range
- History of accommodative (focusing) issues or therapy
Sites / Locations
- Ohio State University College of Optometry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One Week Atropine
Arm Description
0.01% concentration atropine drops
Outcomes
Primary Outcome Measures
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).
Secondary Outcome Measures
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Investigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters.
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Each of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week.
Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best
Change in Intraocular Pressure Using a Tonopen
We will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg.
Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.
Investigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment).
Full Information
NCT ID
NCT03593044
First Posted
June 27, 2018
Last Updated
November 18, 2022
Sponsor
Jeffrey J. Walline, OD PhD
1. Study Identification
Unique Protocol Identification Number
NCT03593044
Brief Title
Side Effects of Atropine (SEA) Study
Acronym
SEA
Official Title
Side Effects of Atropine (SEA) Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey J. Walline, OD PhD
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.
Detailed Description
Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
atropine, photophobia, pupil, reading speed, myopia, Surveys and Questionnaires
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Subjects will take drops for one week and measurements will be taken before and after treatment period.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One Week Atropine
Arm Type
Experimental
Arm Description
0.01% concentration atropine drops
Intervention Type
Drug
Intervention Name(s)
0.01% concentration atropine drops
Other Intervention Name(s)
Atropine Sulfate
Intervention Description
One drop of 0.01% concentration atropine in each eye at night for seven days.
Primary Outcome Measure Information:
Title
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Description
Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Time Frame
Baseline (before) and one week after beginning treatment with drops
Title
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Description
Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).
Time Frame
Baseline (before) and one week after beginning treatment with drops
Secondary Outcome Measure Information:
Title
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Description
Investigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters.
Time Frame
One week after beginning treatment with drops
Title
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Description
Each of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week.
Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best
Time Frame
Baseline (before) and one week after beginning treatment with drops
Title
Change in Intraocular Pressure Using a Tonopen
Description
We will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg.
Time Frame
Baseline (before) and one week after beginning treatment with drops
Title
Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.
Description
Investigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment).
Time Frame
Baseline (before) and one week after beginning treatment with drops
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-N/A
Exclusion Criteria:
Outside of age range
History of accommodative (focusing) issues or therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Walline
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21963266
Citation
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.
Results Reference
background
PubMed Identifier
26218150
Citation
Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.
Results Reference
background
Learn more about this trial
Side Effects of Atropine (SEA) Study
We'll reach out to this number within 24 hrs