Side Effects of Atropine (SEA) Study

Phase 1

Completed

Conditions: Myopia

Interventions: Drug: 0.01% concentration atropine drops

Registration Number: NCT03593044

Lead Sponsor: Jeffrey J. Walline, OD PhD

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

-N/A

Exclusion Criteria

Outside of age range
History of accommodative (focusing) issues or therapy

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One Week Atropine	0.01% concentration atropine drops	0.01% concentration atropine drops

Primary Outcome Measures

Name	Time	Method
Diameter of the Pupil Measured With a Neuroptix Pupillometer	Baseline (before) and one week after beginning treatment with drops	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	Baseline (before) and one week after beginning treatment with drops	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

Name	Time	Method
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor	One week after beginning treatment with drops	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.	Baseline (before) and one week after beginning treatment with 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	Baseline (before) and one week after beginning treatment with drops	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.	Baseline (before) and one week after beginning treatment with drops	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).

Trial Locations

Locations (1): Ohio State University College of Optometry
🇺🇸
Columbus, Ohio, United States
Ohio State University College of Optometry
🇺🇸Columbus, Ohio, United States