Wearing-Off Period of Pharmacological Dilation and Anisocoria

Prisma Health-Upstate

Status and phase

Completed

Phase 4

Conditions

Anisocoria

Treatments

Device: Reichert phoropter

Device: Tono pen AVIA

Drug: Proparacaine Hydrochloride

Drug: Tropicamide

Device: VG4 Gonio

Drug: 1% Pilocarpine

Study type

Interventional

Funder types

Other

Identifiers

NCT05238233

1864081

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

Eye Dilation and Constriction

Experimental group

Description:

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.