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NCT05238233 · ClinicalTrials.gov registry record · Phase 4
Wearing-Off Period of Pharmacological Dilation and Anisocoria
A Phase 4 study, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT05238233 is a Phase 4 study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 11 participants.
The verdict
NCT05238233, a Phase 4 study, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DRUG Tropicamide
- DRUG 1% Pilocarpine
- DRUG Proparacaine Hydrochloride
- DEVICE Tono pen AVIA
- DEVICE VG4 Gonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2023-01-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05238233
The ClinicalTrials.gov registry entry for NCT05238233 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tropicamide is the first listed.
NCT05238233 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05238233 about?
NCT05238233 is a clinical study titled "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. Ea...
What is the current status of trial NCT05238233?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2022-04-01. Estimated completion is 2023-01-17.
What interventions are being tested in trial NCT05238233?
The interventions under investigation include: Tropicamide (DRUG), 1% Pilocarpine (DRUG), Proparacaine Hydrochloride (DRUG), Tono pen AVIA (DEVICE), VG4 Gonio (DEVICE).
Who is sponsoring clinical trial NCT05238233?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
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