Side Effects of Atropine (SEA) Study (SEA)

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: 0.01% concentration atropine drops

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-N/A

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: One Week Atropine; 0.01% concentration atropine drops	Drug: 0.01% concentration atropine drops; One drop of 0.01% concentration atropine in each eye at night for seven days.; Other Names: Atropine Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Jeffrey J. Walline, OD PhD
• Investigators: Principal Investigator: Jeffrey Walline, Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 23, 2018
• Primary Completion (ACTUAL): January 17, 2019
• Study Completion (ACTUAL): January 17, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: atropine; photophobia; myopia; pupil; Surveys and Questionnaires; reading speed
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 2018H0224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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