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NCT04701593 · ClinicalTrials.gov registry record · Phase 4
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
A Phase 4 study of Retinal Detachment, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04701593 is a Phase 4 study of Retinal Detachment that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 14 participants, below the 1,089-participant average among 3 other Retinal Detachment trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04701593, a Phase 4 study of Retinal Detachment, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery. METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide 40mg/mL
Study Locations (1)
Virginia
- Vistar Eye Centers - Roanoke
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-01-03 |
| Est. Completion | 2022-10-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04701593
The ClinicalTrials.gov registry entry for NCT04701593 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,089-participant average among 3 other Retinal Detachment trials with a reported enrollment target (99% lower). The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retinal Detachment appearing as the primary indexed condition, and to 1 intervention - of which Triamcinolone Acetonide 40mg/mL is the first listed.
NCT04701593 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT04701593 about?
NCT04701593 is a clinical study titled "Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery". PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain...
What is the current status of trial NCT04701593?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2020-01-03. Estimated completion is 2022-10-20.
What conditions does trial NCT04701593 study?
This clinical trial studies the following conditions: Retinal Detachment.
What interventions are being tested in trial NCT04701593?
The interventions under investigation include: Triamcinolone Acetonide 40mg/mL (DRUG).
Who is sponsoring clinical trial NCT04701593?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04701593 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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