Your session is about to expire
← Back to Search
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery
Phase 4
Waitlist Available
Led By Vishak J John, MD
Research Sponsored by Virginia Polytechnic Institute and State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day post-op
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether sub-tenon's irrigation with triamcinolone acetonide at the time of surgery can reduce pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.
Eligible Conditions
- Retinal Detachment
- Retinal Pigment Epithelial Detachment
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cumulative amount used was assessed at one week after operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cumulative amount used was assessed at one week after operation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Post Operative Pain Day 1
Secondary study objectives
Pain Medication Use (Tylenol in mg)
Post Operative Pain Week 1
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (Triamcinolone Acetonide)Experimental Treatment1 Intervention
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
Group II: ControlActive Control1 Intervention
No additional drug given
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triamcinolone Acetonide 40mg/mL
2020
Completed Phase 4
~390
Find a Location
Who is running the clinical trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
156 Previous Clinical Trials
25,731 Total Patients Enrolled
Vishak J John, MDPrincipal InvestigatorVirginia Tech, Vistar Eye Center