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Students at the School of Medicine Greenville will be asked to participate in this study.
The aim of this study is to better understand when medical imaging is needed for patients with anisocoria (unequal pupil size).
Participation in the study includes up to 3 visits over a period of one week. Each study visit will last about 30 minutes.
At the first visit, participants will be screened for hyperopia using a phoropter, have their intraocular pressures taken using a tono-pen, and have their iridocorneal angle measured using gonioscopy at the ophthalmology clinic. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens exam. Participants will also be asked to complete three forms.
Participants will be asked to return to the clinic on a scheduled day within one week of the screening visit to have their left eye dilated. At this visit, the diameter of the pupil will be measured using a Near card in a windowless room with a set light-level. Then, the participant will receive one drop of tropicamide in the left eye. After the drops have had time to take effect, which will be about 20-30 minutes later, the diameter of the pupil will be measured again.
Participants will then be asked to return to the clinic in 3-4 hours. At this time, the diameter of the pupil will be measured again.
The third type of eye drop used in this study is 1% pilocarpine. 1 % pilocarpine will briefly constrict the eyes. One drop of 1% pilocarpine will be administered to left eye, and the change in pupillary diameter will be measured, if any. It will take about 10-15 minutes for the 1% pilocarpine to take effect.
Participants may be required to attend 2 additional 30-minute visits on a third day depending on how their eyes respond to the drops.
This study will recruit about 10-15 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye Dilation and Constriction | Experimental | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropicamide | Drug | One drop will be given to participants |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye | Measurement of pupil diameter | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eye Dilation and Constriction - Left Eye | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia >+1 diopter |
| FG001 | Eye Dilation and Constriction - Right Eye | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia >+1 diopter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eye Dilation and Constriction | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia >+1 diopter |
| 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 | Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye | Measurement of pupil diameter | Posted | Count of Participants | Participants | 4 hours |
|
1 day
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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 | Eye Dilation and Constriction | Participants screened for hyperopia >+1 diopter using a phoropter, have their intraocular pressures measured using a tono pen, and have their iridocorneal angle measured with a gonio lens. Proparacaine hydrochloride 0.5% eye drops will be used to numb the eyes before measuring intraocular pressures and prior to gonio lens. The following day, the participant will receive one drop of tropicamide and one drop of 1% pilocarpine in the left eye. If the left eye has no response to the 1% pilocarpine, or if the diameter of the pupil returned to baseline size, we will ask participants to come back to the clinic on another day to have the process repeated in the right eye. Tropicamide: One drop will be given to participants 1% Pilocarpine: One drop will be given to participants Proparacaine Hydrochloride: One drop will be given to participants Tono pen AVIA: Participant intraocular pressures measured VG4 Gonio: Participant iridocorneal angle measured Reichert phoropter: Participant screened for hyperopia >+1 diopter |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimee Hanvey | Prisma Health | 864-760-7350 | aimee.hanvey@prismahealth.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2022 | Feb 13, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D015875 | Anisocoria |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014331 | Tropicamide |
| D010862 | Pilocarpine |
| C005717 | proxymetacaine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000470 | Alkaloids |
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| 1% Pilocarpine |
| Drug |
One drop will be given to participants |
|
| Proparacaine Hydrochloride | Drug | One drop will be given to participants |
|
| Tono pen AVIA | Device | Participant intraocular pressures measured |
|
| VG4 Gonio | Device | Participant iridocorneal angle measured |
|
| Reichert phoropter | Device | Participant screened for hyperopia >+1 diopter |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |