Clinical trial NCT03593044: Side Effects of Atropine (SEA) Study
Official title: Side Effects of Atropine (SEA) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myopia
Keywords: atropine
photophobia
pupil
reading speed
myopia
Surveys and Questionnaires
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will take drops for one week and measurements will be taken before and after treatment period.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

-N/A

Exclusion Criteria:

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

Primary outcomes:
measure: Diameter of the Pupil Measured With a Neuroptix Pupillometer
timeFrame: Baseline (before) and one week after beginning treatment with drops
measure: Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
timeFrame: Baseline (before) and one week after beginning treatment with drops
Secondary outcomes:
measure: Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
timeFrame: One week after beginning treatment with drops
measure: Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
timeFrame: Baseline (before) and one week after beginning treatment with drops
measure: Change in Intraocular Pressure Using a Tonopen
timeFrame: Baseline (before) and one week after beginning treatment with drops
measure: 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.
timeFrame: Baseline (before) and one week after beginning treatment with drops
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: Ohio State University
name: Jeffrey Walline
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.