Side Effects of Atropine (SEA) Study

Myopia Clinical Trial

— SEA  

Official title:

Side Effects of Atropine (SEA) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593044
• Other study ID #: 2018H0224
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 23, 2018
• Est. completion date: January 17, 2019

Study information

• Verified date: November 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 30 Years

Eligibility

Inclusion Criteria:

-N/A

Exclusion Criteria:

• Outside of age range

• History of accommodative (focusing) issues or therapy

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 0.01% concentration atropine drops
One drop of 0.01% concentration atropine in each eye at night for seven days.

Locations

Country	Name	City	State
United States	Ohio State University College of Optometry	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jeffrey J. Walline, OD PhD

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline (before) and one week after beginning treatment with drops
Primary	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).	Baseline (before) and one week after beginning treatment with drops
Secondary	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.	One week after beginning treatment with drops
Secondary	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	Baseline (before) and one week after beginning treatment with drops
Secondary	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.	Baseline (before) and one week after beginning treatment with drops
Secondary	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).	Baseline (before) and one week after beginning treatment with drops