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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One Week Atropine | Experimental | 0.01% concentration atropine drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% concentration atropine drops | Drug | One drop of 0.01% concentration atropine in each eye at night for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diameter of the Pupil Measured With a Neuroptix Pupillometer | Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter | Baseline (before) and one week after beginning treatment with drops |
| Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment). | Baseline (before) and one week after beginning treatment with drops |
| Measure | Description | Time Frame |
|---|---|---|
| Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Investigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters. | One week after beginning treatment with drops |
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Inclusion Criteria:
-N/A
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Walline | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University College of Optometry | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21963266 | Background | 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. | |
| 26218150 | Background |
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Subjects aged 22 to 26 years were enrolled in the study from July 2018 to January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | One Week Atropine | 0.01% concentration atropine drops 0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One Week Atropine | 0.01% concentration atropine drops 0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diameter of the Pupil Measured With a Neuroptix Pupillometer | Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter | Posted | Mean | Standard Deviation | millimeters | Baseline (before) and one week after beginning treatment with drops |
|
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | One Week Atropine | 0.01% concentration atropine drops 0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Walline | The Ohio State University College of Optometry | (614) 247-6840 | walline.1@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2021 | Jan 6, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 6, 2018 | May 20, 2022 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D020795 | Photophobia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
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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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Subjects will take drops for one week and measurements will be taken before and after treatment period.
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| Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Each of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week. Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best | Baseline (before) and one week after beginning treatment with drops |
| Change in Intraocular Pressure Using a Tonopen | We will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg. | Baseline (before) and one week after beginning treatment with drops |
| 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. | Investigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment). | Baseline (before) and one week after beginning treatment with drops |
| 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Spherical equivalent manifest refraction | The spherical equivalent manifest refraction equals the spherical component of the manifest refraction plus one-half of the cylinder component (astigmatism) of the manifest refraction. This is a measure of the refractive error (near-sightedness or far-sightedness) of the subject's eye and is performed using an instrument called a phoropter with multiple lenses of differing powers to investigate which lens makes the patient's vision look the clearest. | Mean | Standard Deviation | diopters |
|
| Eye color | Count of Participants | Participants |
|
|
|
| Primary | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment). | Posted | Mean | Standard Deviation | logMAR | Baseline (before) and one week after beginning treatment with drops |
|
|
|
|
| Secondary | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Investigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters. | Posted | Mean | Standard Deviation | diopters | One week after beginning treatment with drops |
|
|
|
|
| Secondary | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Each of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week. Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best | Posted | Mean | Standard Deviation | score on a question from 1 to 10 | Baseline (before) and one week after beginning treatment with drops |
|
|
|
|
| Secondary | Change in Intraocular Pressure Using a Tonopen | We will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg. | Posted | Mean | Standard Deviation | millimeters Mercury | Baseline (before) and one week after beginning treatment with drops |
|
|
|
|
| Secondary | 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. | Investigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment). | Posted | Mean | Standard Deviation | cycles per minute | Baseline (before) and one week after beginning treatment with drops |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
|
| High contrast near visual acuity adter administration of drops for one week |
|
| Low contrast visual acuity before drops |
|
| Low contrast visual acuity after administration of drops for one week |
|
| 0.77 |
| Other |
| Low contrast distance visual acuity | t-test, 2 sided | 0.82 | Other |
|
| Accommodative lag after administration of drops for one week |
|
| Accommodative facility before drops |
|
| Accommodative facility after administration of drops for one week |
|
| Other |
| Accommodative facility | t-test, 2 sided | 0.24 | Other |
| Title | Measurements |
|---|---|
|
| Ghost images after drops |
|
| Strain/tiredness before drops |
|
| strain/tiredness after drops |
|
| Changing vision before drops |
|
| Changing vision after drops |
|
| Headache frequency before drops |
|
| Headache frequency after drops |
|
| Distance clarity before drops |
|
| Distance clarity after drops |
|
| Computer clarity before drops |
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| Computer clarity after drops |
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| Small print clarity before drops |
|
| Small print clarity after drops |
|
| Vision during sports/hobbies before drops |
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| Vision during sports/hobbies after drops |
|
| Overall vision before drops |
|
| Overall vision after drops |
|
| Light sensitivity before drops |
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| Light sensitivity after drops |
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| Discomfort during bright light before drops |
|
| Discomfort during bright light after drops |
|
| Other |
| Strain/tiredness | t-test, 2 sided | 0.9 | Other |
| Changing vision | t-test, 2 sided | 0.9 | Other |
| Headache frequency | t-test, 2 sided | 0.3 | Other |
| Distance clarity | t-test, 2 sided | 0.7 | Other |
| Computer clarity | t-test, 2 sided | 0.3 | Other |
| Small print clarity | t-test, 2 sided | 0.1 | Other |
| Vision during sports/hobbies | t-test, 2 sided | 1.0 | Other |
| Overall vision | t-test, 2 sided | 0.2 | Other |
| Light sensitivity | t-test, 2 sided | 0.7 | Other |
| Discomfort during bright light | t-test, 2 sided | 0.002 | Other |
|
| Intraocular pressure of left eyes after administration of drops for one week |
|
| Other |