Skip to main content
OpenTrials
Completed

NCT Number: NCT05238233

Wearing-Off Period of Pharmacological Dilation and Anisocoria

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tropicamide

Drug

One drop will be given to participants

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

Primary outcomes

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

    Time frame: 4 hours

    Measurement of pupil diameter

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Registry information

Official study title

The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.