Wearing-Off Period of Pharmacological Dilation and Anisocoria

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Recruiting
CT.gov ID
NCT05238233
Collaborator
(none)
15
1
1
23
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tropicamide
  • Drug: 1% Pilocarpine
  • Drug: Proparacaine Hydrochloride
  • Device: Tono pen AVIA
  • Device: VG4 Gonio
  • Device: Reichert phoropter
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Wearing-Off Period of Pharmacological Dilation: An Addendum to the Management of Anisocoria
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Tropicamide
One drop will be given to participants

Drug: 1% Pilocarpine
One drop will be given to participants

Drug: Proparacaine Hydrochloride
One drop will be given to participants

Device: Tono pen AVIA
Participant intraocular pressures measured

Device: VG4 Gonio
Participant iridocorneal angle measured

Device: Reichert phoropter
Participant screened for hyperopia >+1 diopter

Outcome Measures

Primary Outcome Measures

  1. Measurement of pupil diameter after one drop of Tropicamide [30 minutes]

    Measurement of pupil diameter

  2. Measurement of pupil diameter after one drop of Tropicamide [4 hours]

    Measurement of pupil diameter

  3. Measurement of pupil diameter aver one drop of 1% pilocarpine [10 minutes]

    Measurement of pupil diameter

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prisma Health Greenville South Carolina United States 29605

Sponsors and Collaborators

  • Prisma Health-Upstate

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prisma Health-Upstate
ClinicalTrials.gov Identifier:
NCT05238233
Other Study ID Numbers:
  • 1864081
First Posted:
Feb 14, 2022
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2022