Side Effects of Atropine (SEA) Study

NCT ID: NCT03593044

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-01-17

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

One Week Atropine

0.01% concentration atropine drops

Group Type: EXPERIMENTAL

0.01% concentration atropine drops

Intervention Type: DRUG

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

Interventions

0.01% concentration atropine drops

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

Intervention Type: DRUG

Other Intervention Names

Atropine Sulfate

Eligibility Criteria

Inclusion Criteria

-N/A

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jeffrey J. Walline, OD PhD

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey J. Walline, OD PhD

Associate Dean For Research

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey Walline

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University College of Optometry

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21963266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26218150 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018H0224

Identifier Type: -

Identifier Source: org_study_id