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The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Experimental | All participants will receive all four drops in randomized order |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% atropine | Drug | 0.01%, room temp, Lab A |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Return to Baseline Comfort | 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:
| We will record comfort of each drop for a maximum of 25 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Who Return to Baseline Comfort Within 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University College of Optometry | Columbus | Ohio | 43210-1240 | United States |
I do not plan to share the data
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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Participants will have one drop of low concentration atropine placed in one eye four different times in random order
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The participant will not know which of the four drops is being administered in random order
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| 0.05% atropine | Drug | 0.05%, room temp, Lab A |
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| 0.05% atropine | Drug | 0.05%, refrigerated, Lab A |
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| 0.05% atropine | Drug | 0.05%, room temperature, Lab B |
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| We will record comfort of each drop for a maximum of 25 seconds |
| Peak Comfort Score | We will compare the peak comfort score, meaning the most discomfort, for the following drop comparisons:
| We will record comfort of each drop for a maximum of 25 seconds |
| Average Comfort Score | We will compare the average comfort score over 25 seconds for the following drop comparisons:
| We will record comfort of each drop for a maximum of 25 seconds |
| Correlation Between Peak Comfort Score and Corneal Sensitivity | 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) | We will record comfort of the drop for a maximum of 25 seconds |
| Correlation Between Peak Comfort Score and Iris Color | 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) | We will record comfort of the drop for a maximum of 25 seconds |
| Correlation Between Peak Comfort Score and the Perceived Victim Scale Score | 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) | We will record comfort of the drop for a maximum of 25 seconds |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |