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Side Effects of Atropine (SEA) Study

J

Jeffrey J. Walline, OD PhD

Status and phase

Completed
Phase 2
Phase 1

Conditions

Myopia

Treatments

Drug: 0.01% concentration atropine drops

Study type

Interventional

Funder types

Other

Identifiers

NCT03593044
2018H0224

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

21 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

-N/A

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

One Week Atropine
Experimental group
Description:
0.01% concentration atropine drops
Treatment:
Drug: 0.01% concentration atropine drops

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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