CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Tropicamide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05238233
NCT05238233Phase 4Completed

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

Prisma Health-Upstate·interventional·Posted Feb 14, 2022·Updated Mar 7, 2023

In Brief

A Phase 4 clinical trial evaluating Tropicamide, 1% Pilocarpine, and 4 other interventions for Anisocoria. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnisocoria
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedFeb 14, 2022
Enrollment StartApr 1, 2022
Primary CompletionJan 17, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.4 years ago

Interventions

Tropicamidedrug

One drop will be given to participants

1% Pilocarpinedrug

One drop will be given to participants

Proparacaine Hydrochloridedrug

One drop will be given to participants

Tono pen AVIAdevice

Participant intraocular pressures measured

VG4 Goniodevice

Participant iridocorneal angle measured

Reichert phoropterdevice

Participant screened for hyperopia \>+1 diopter