Myopia
Conditions
Keywords
atropine, photophobia, pupil, reading speed, myopia, Surveys and Questionnaires
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.
Interventions
One drop of 0.01% concentration atropine in each eye at night for seven days.
Sponsors
Jeffrey J. Walline, OD PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will take drops for one week and measurements will be taken before and after treatment period.
Eligibility
Sex/Gender
ALL
Age
21 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
-N/A
Exclusion criteria
* Outside of age range * History of accommodative (focusing) issues or therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter of the Pupil Measured With a Neuroptix Pupillometer | Baseline (before) and one week after beginning treatment with drops | 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 |
| Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | Baseline (before) and one week after beginning treatment with drops | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | One week after beginning treatment with drops | 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. |
| Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Baseline (before) and one week after beginning treatment with 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 |
| Change in Intraocular Pressure Using a Tonopen | Baseline (before) and one week after beginning treatment with drops | 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. |
| 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. | Baseline (before) and one week after beginning treatment with drops | 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). |
Countries
United States
Participant flow
Recruitment details
Subjects aged 22 to 26 years were enrolled in the study from July 2018 to January 2019.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | One Week Atropine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Age, Continuous | 23.9 years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Eye color Blue | 11 Participants |
| Eye color Brown | 12 Participants |
| Eye color Green | 7 Participants |
| Eye color Hazel | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 9 Participants |
| Spherical equivalent manifest refraction | -3.12 diopters STANDARD_DEVIATION 2.87 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: Baseline (before) and one week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | Diameter of the Pupil Measured With a Neuroptix Pupillometer | Photopic pupil size before administration of drops | 4.9 millimeters | Standard Deviation 0.8 |
| One Week Atropine | Diameter of the Pupil Measured With a Neuroptix Pupillometer | Photopic pupil size after administration of drops for one week | 5.1 millimeters | Standard Deviation 0.6 |
| One Week Atropine | Diameter of the Pupil Measured With a Neuroptix Pupillometer | Mesopic pupil size before administration of drops | 5.9 millimeters | Standard Deviation 0.66 |
| One Week Atropine | Diameter of the Pupil Measured With a Neuroptix Pupillometer | Mesopic pupil size after administration of drops for one week | 5.9 millimeters | Standard Deviation 0.7 |
Comparison: Photopic pupil sizep-value: 0.002t-test, 2 sided
Comparison: Mesopic pupil sizep-value: 0.66t-test, 2 sided
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).
Time frame: Baseline (before) and one week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | High contrast near visual acuity adter administration of drops for one week | -0.2 logMAR | Standard Deviation 0.1 |
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | Low contrast visual acuity before drops | 0.0 logMAR | Standard Deviation 0.1 |
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | High contrast distance visual acuity before drops | -0.1 logMAR | Standard Deviation 0.1 |
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | High contrast distance visual acuity after administration of drops for one week | -0.1 logMAR | Standard Deviation 0.1 |
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | High contrast near visual acuity before drops | -0.2 logMAR | Standard Deviation 0.1 |
| One Week Atropine | Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts | Low contrast visual acuity after administration of drops for one week | 0.0 logMAR | Standard Deviation 0.1 |
Comparison: High contrast distance visual acuityp-value: 0.96t-test, 2 sided
Comparison: High contrast near visual acuityp-value: 0.77t-test, 2 sided
Comparison: Low contrast distance visual acuityp-value: 0.82t-test, 2 sided
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).
Time frame: Baseline (before) and one week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | 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. | Accommodative facility before drops | 13.6 cycles per minute | Standard Deviation 4 |
| One Week Atropine | 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. | Accommodative facility after administering drops for one week | 14.0 cycles per minute | Standard Deviation 3.8 |
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.
Time frame: Baseline (before) and one week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | Change in Intraocular Pressure Using a Tonopen | Intraocular pressure of right eyes before drops | 15.5 millimeters Mercury | Standard Deviation 2.9 |
| One Week Atropine | Change in Intraocular Pressure Using a Tonopen | Intraocular pressure of right eyes after administration of drops for one week | 17.0 millimeters Mercury | Standard Deviation 2.8 |
| One Week Atropine | Change in Intraocular Pressure Using a Tonopen | Intraocular pressure of left eyes before drops | 15.7 millimeters Mercury | Standard Deviation 2.8 |
| One Week Atropine | Change in Intraocular Pressure Using a Tonopen | Intraocular pressure of left eyes after administration of drops for one week | 16.4 millimeters Mercury | Standard Deviation 3.1 |
Comparison: Right eye intraocular pressurep-value: 0.001t-test, 2 sided
Comparison: Left eye intraocular pressurep-value: 0.05t-test, 2 sided
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
Time frame: Baseline (before) and one week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Glare before drops | 8.7 score on a question from 1 to 10 | Standard Deviation 1.9 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Glare after drops | 9.0 score on a question from 1 to 10 | Standard Deviation 1.3 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Ghost images before drops | 9.8 score on a question from 1 to 10 | Standard Deviation 0.9 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Ghost images after drops | 9.7 score on a question from 1 to 10 | Standard Deviation 0.7 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Strain/tiredness before drops | 8.3 score on a question from 1 to 10 | Standard Deviation 1.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | strain/tiredness after drops | 8.7 score on a question from 1 to 10 | Standard Deviation 1.6 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Changing vision before drops | 9.4 score on a question from 1 to 10 | Standard Deviation 1.2 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Changing vision after drops | 9.4 score on a question from 1 to 10 | Standard Deviation 0.9 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Headache frequency before drops | 1.6 score on a question from 1 to 10 | Standard Deviation 0.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Headache frequency after drops | 1.7 score on a question from 1 to 10 | Standard Deviation 0.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Distance clarity before drops | 8.8 score on a question from 1 to 10 | Standard Deviation 1.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Distance clarity after drops | 8.7 score on a question from 1 to 10 | Standard Deviation 1.2 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Computer clarity before drops | 9.5 score on a question from 1 to 10 | Standard Deviation 0.8 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Computer clarity after drops | 9.3 score on a question from 1 to 10 | Standard Deviation 1 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Small print clarity before drops | 9.5 score on a question from 1 to 10 | Standard Deviation 1.1 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Small print clarity after drops | 9.1 score on a question from 1 to 10 | Standard Deviation 1 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Vision during sports/hobbies before drops | 9.6 score on a question from 1 to 10 | Standard Deviation 0.6 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Vision during sports/hobbies after drops | 9.6 score on a question from 1 to 10 | Standard Deviation 0.6 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Overall vision before drops | 9.4 score on a question from 1 to 10 | Standard Deviation 1 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Overall vision after drops | 9.1 score on a question from 1 to 10 | Standard Deviation 0.9 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Light sensitivity before drops | 2.8 score on a question from 1 to 10 | Standard Deviation 2.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Light sensitivity after drops | 3.1 score on a question from 1 to 10 | Standard Deviation 2.5 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Discomfort during bright light before drops | 2.7 score on a question from 1 to 10 | Standard Deviation 1.9 |
| One Week Atropine | Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. | Discomfort during bright light after drops | 2.0 score on a question from 1 to 10 | Standard Deviation 1.7 |
Comparison: Glarep-value: 0.3t-test, 2 sided
Comparison: Ghost imagesp-value: 0.5t-test, 2 sided
Comparison: Strain/tirednessp-value: 0.9t-test, 2 sided
Comparison: Changing visionp-value: 0.9t-test, 2 sided
Comparison: Headache frequencyp-value: 0.3t-test, 2 sided
Comparison: Distance clarityp-value: 0.7t-test, 2 sided
Comparison: Computer clarityp-value: 0.3t-test, 2 sided
Comparison: Small print clarityp-value: 0.1t-test, 2 sided
Comparison: Vision during sports/hobbiesp-value: 1t-test, 2 sided
Comparison: Overall visionp-value: 0.2t-test, 2 sided
Comparison: Light sensitivityp-value: 0.7t-test, 2 sided
Comparison: Discomfort during bright lightp-value: 0.002t-test, 2 sided
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.
Time frame: One week after beginning treatment with drops
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative amplitude before drops | 8.1 diopters | Standard Deviation 1.2 |
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative amplitude after administration of drops for one week | 8.5 diopters | Standard Deviation 1.3 |
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative lag before drops | -0.8 diopters | Standard Deviation 1.7 |
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative lag after administration of drops for one week | -0.9 diopters | Standard Deviation 0.8 |
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative facility before drops | 13.6 diopters | Standard Deviation 4 |
| One Week Atropine | Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor | Accommodative facility after administration of drops for one week | 14.0 diopters | Standard Deviation 3.8 |
Comparison: Accommodative amplitudep-value: 0.1t-test, 2 sided
Comparison: Accommodative lagp-value: 0.66t-test, 2 sided
Comparison: Accommodative facilityp-value: 0.24t-test, 2 sided