Clinical trial NCT05238233: Wearing-Off Period of Pharmacological Dilation and Anisocoria
Official title: The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anisocoria
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Number of Participants With Constricting Response to Pilocarpine 1% in the Pharmacologically Dilated Eye
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
References: