Wearing-Off Period of Pharmacological Dilation and Anisocoria

NCT05238233 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 1864081
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye

  Measurement of pupil diameter

  4 hours

Study Arms (1)

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.

Drug: Tropicamide; Drug: 1% Pilocarpine; Drug: Proparacaine Hydrochloride; Device: Tono pen AVIA; Device: VG4 Gonio; Device: Reichert phoropter

Interventions

Tropicamide DRUG

One drop will be given to participants

Eye Dilation and Constriction

1% Pilocarpine DRUG

One drop will be given to participants

Eye Dilation and Constriction

Proparacaine Hydrochloride DRUG

One drop will be given to participants

Eye Dilation and Constriction

Tono pen AVIA DEVICE

Participant intraocular pressures measured

Eye Dilation and Constriction

VG4 Gonio DEVICE

Participant iridocorneal angle measured

Eye Dilation and Constriction

Reichert phoropter DEVICE

Participant screened for hyperopia \>+1 diopter

Eye Dilation and Constriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Anisocoria

Interventions

Tropicamide; Pilocarpine; proxymetacaine

Condition Hierarchy (Ancestors)

Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkaloids

Results Point of Contact

• Title: Aimee Hanvey
• Organization: Prisma Health

aimee.hanvey@prismahealth.org

864-760-7350

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: April 1, 2022
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)