Wearing-Off Period of Pharmacological Dilation and Anisocoria

NCT ID: NCT05238233

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-01-17

Brief Summary

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.

Conditions

Anisocoria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tropicamide

Intervention Type: DRUG

One drop will be given to participants

1% Pilocarpine

Intervention Type: DRUG

One drop will be given to participants

Proparacaine Hydrochloride

Intervention Type: DRUG

One drop will be given to participants

Tono pen AVIA

Intervention Type: DEVICE

Participant intraocular pressures measured

VG4 Gonio

Intervention Type: DEVICE

Participant iridocorneal angle measured

Reichert phoropter

Intervention Type: DEVICE

Participant screened for hyperopia \>+1 diopter

Interventions

Tropicamide

One drop will be given to participants

Intervention Type: DRUG

1% Pilocarpine

One drop will be given to participants

Intervention Type: DRUG

Proparacaine Hydrochloride

One drop will be given to participants

Intervention Type: DRUG

Tono pen AVIA

Participant intraocular pressures measured

Intervention Type: DEVICE

VG4 Gonio

Participant iridocorneal angle measured

Intervention Type: DEVICE

Reichert phoropter

Participant screened for hyperopia \>+1 diopter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Student at the University of South Carolina School of Medicine Greenville
• Healthy participants
• No significant ophthalmological history

Exclusion Criteria

• a history of angle closure glaucoma, any other type of glaucoma
• any elevated eye pressure readings
• any history of intraocular surgery or procedure.
• if the participant is found to be hyperopic to >+1 diopter, has an intraocular pressure of > 22 mm Hg in either eye, or displays an iridocorneal angle where trabecular meshwork
• known allergy to natural rubber latex

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prisma Health

Greenville, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1864081

Identifier Type: -

Identifier Source: org_study_id