Myopia
Conditions
Keywords
atropine
Brief summary
The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.
Detailed description
After being informed about the study and potential risks, all participants giving written informed consent will answer questions about themselves and complete a 12-question survey about the need for drama. An examiner will then measure the sensitivity of the cornea (clear window on the front of the eye) by touching the cornea with a thin thread that shortens until it is first detected by the participant. After that, an examiner will place a drop of atropine in the right eye, and the participant will rate the eye comfort for 25 seconds using a computerized slide scale. Five minutes after the first drop, the examiner will put a drop in the left eye and the participant will rate the comfort for 25 seconds. The examiner will then repeat that process one more time with each eye. The drops placed in the eyes will be 0.01% atropine at room temperature from Lab A, 0.05% atropine at room temperature from Lab A, 0.05% atropine refrigerated from Lab A, or 0.05% atropine at room temperature from Lab B. The drops will be placed in the eyes in random order, so the participant won't know which one is being administered. At the very end, the participant will rate how likely s/he would be to take a low concentration atropine eye drop every day in each eye if it may delay the onset of nearsightedness from 1 (definitely not) to 10 (definitely would).
Interventions
DRUG0.01% atropine
0.01%, room temp, Lab A
DRUG0.05% atropine
0.05%, room temp, Lab A
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Masking description
The participant will not know which of the four drops is being administered in random order
Intervention model description
Participants will have one drop of low concentration atropine placed in one eye four different times in random order
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years and older
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return to Baseline Comfort | We will record comfort of each drop for a maximum of 25 seconds | We will compare the amount of time that it takes a participant to report that the eye comfort is 0, meaning that it returned to baseline comfort, for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Comfort Score | We will record comfort of each drop for a maximum of 25 seconds | We will compare the peak comfort score, meaning the most discomfort, for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
| Average Comfort Score | We will record comfort of each drop for a maximum of 25 seconds | We will compare the average comfort score over 25 seconds for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
| Proportion Who Return to Baseline Comfort Within 25 Seconds | We will record comfort of each drop for a maximum of 25 seconds | We will compare the proportion of participants who report the eye comfort is 0, meaning that it returned to baseline comfort, for the following drop comparisons: 1. 0.01% at room temperature from Lab A and 0.05% at room temperature from Lab A (comparing concentrations) 2. 0.05% at room temperature from Lab A and 0.05% refrigerated from Lab A (comparing temperatures) 3. 0.05% at room temperature from Lab A and 0.05% at room temperature from Lab B (comparing labs) Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
| Correlation Between Peak Comfort Score and Iris Color | We will record comfort of the drop for a maximum of 25 seconds | We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and iris color Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
| Correlation Between Peak Comfort Score and the Perceived Victim Scale Score | We will record comfort of the drop for a maximum of 25 seconds | We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and the Persistent Perceived Victim scale score of the Need for Drama Survey Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
| Correlation Between Peak Comfort Score and Corneal Sensitivity | We will record comfort of the drop for a maximum of 25 seconds | We will determine the correlation coefficient between the peak pain score when taking 0.05% atropine at room temperature from Lab A and corneal sensitivity Comfort scale ranges from 0 (no discomfort) to 10 (extreme discomfort) |
Countries
United States
Outcome results
None listed