← Back to Search

Anti-fibrinolytic

Tranexamic Acid for Swollen Eyes

Phase 4
Waitlist Available
Led By Anne Barmettler
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are at least 18 years of age
Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
Must not have
Any patient undergoing multiple simultaneous periocular surgical procedures
Any history of previous orbital surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days postoperatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial aims to study the effects of tranexamic acid on reducing postoperative bruising and swelling around the eyes in orbital surgery. Tranexamic acid is a medication that helps reduce bleeding by stabil

Who is the study for?
This trial is for adults over 18 who can consent and are undergoing orbital surgery, like decompressions or fracture repairs. It's not suitable for those unable to give consent or meet the inclusion criteria.
What is being tested?
The study tests if Tranexamic acid (TXA), given locally or systemically, reduces swelling and bruising after orbital surgery compared to normal saline solutions.
What are the potential side effects?
Potential side effects of TXA may include nausea, diarrhea, vomiting, dizziness, and rarely blood clots. Normal saline typically has minimal risk but may cause vein irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I am having surgery on my eye socket.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am having more than one eye surgery at the same time.
Select...
I have had surgery on my eye socket before.
Select...
I have bruising or swelling around my eyes before surgery.
Select...
I have had a stroke or seizure in the past.
Select...
I have a history of bleeding or clotting disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Degree of Ecchymosis
Degree of Edema
Secondary study objectives
Other side effects
Patient Satisfaction with ecchymosis
Patient Satisfaction with edema

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: Local TXAExperimental Treatment2 Interventions
1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision
Group II: Group 1: IV TXAExperimental Treatment2 Interventions
1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery
Group III: Group 3: ControlPlacebo Group2 Interventions
Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid injection
2021
Completed Phase 4
~3060

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,320 Total Patients Enrolled
Anne BarmettlerPrincipal InvestigatorMontefiore Medical Center/Albert Einstein College of Medicine
1 Previous Clinical Trials
100 Total Patients Enrolled
~100 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top