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Triamcinolone Injections for Choroidal Effusions Post Glaucoma Surgery (TRICEPS Trial)
Phase 4
Recruiting
Led By Catherine M Birt, MD FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age more than 18 years old
Patients who have had glaucoma surgery at Sunnybrook Health Sciences Centre and / or Kensington Eye Institute and developed choroidal effusions that do not improve after one week of standard medical treatment (Trabeculectomy, Combined Phaco-trabeculectomy, Glaucoma tube Shunts, postoperative 5-FU needling, and laser suture lysis are all considered as eligible Glaucoma surgeries/Procedures)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month visit
Awards & highlights
TRICEPS Trial Summary
This trial is testing whether an anti-inflammatory drug can help heal a complication from glaucoma surgery.
Who is the study for?
This trial is for patients over 18 who've had glaucoma surgery and developed persistent choroidal effusions at Sunnybrook Health Sciences Centre or Kensington Eye Institute. They must have seen no improvement after a week of standard treatment, be fluent in English, able to consent, and not pregnant or agree to use contraception.Check my eligibility
What is being tested?
The study tests if Triamcinolone injections can speed up the healing of choroidal effusions post-glaucoma surgery compared to a sham procedure. Both groups will continue with standard eye drop treatments while their recovery times are measured.See study design
What are the potential side effects?
Triamcinolone may cause increased eye pressure, cataract formation, infection risk inside the eye (endophthalmitis), and possible decrease in vision due to its anti-inflammatory properties.
TRICEPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I had glaucoma surgery and my condition didn't improve after a week of standard treatment.
TRICEPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week to three months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week to three months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to resolution
Secondary outcome measures
Complications
IOP
Medications
+1 moreTRICEPS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: InjectionActive Control1 Intervention
Patients placed in a semi supine position. A cotton-tipped applicator saturated with proparacaine 0.5% (Alcaine, Alcon Labs) is placed into the conjunctival fornix of the supero-temporal quadrant for 5 minutes following initial proparacaine drops.
After anaesthetic medication is placed, 1mL of a 40 mg/ml suspension of triamcinolone acetonide is injected through the superotemporal conjunctival fornix using a 25 Gauge needle, 5/8 inch length on a 3 ml syringe, following the contour of the globe with the needle, external to sclera for the full length of the needle such that the needle tip is ultimately positioned immediately posterior to the macula with the bevel down.
Group II: ControlPlacebo Group1 Intervention
Patients placed in a semi supine position. A cotton-tipped applicator saturated with proparacaine 0.5% (Alcaine, Alcon Labs) is placed into the conjunctival fornix of the supero-temporal quadrant for 5 minutes following initial proparacaine drops.
After anaesthetic medication is placed, a 3 ml syringe will be placed into the superotemporal conjunctival fornix but no needle is present and no drug injected.
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,417 Total Patients Enrolled
4 Trials studying Glaucoma
326 Patients Enrolled for Glaucoma
Catherine M Birt, MD FRCSCPrincipal InvestigatorSunnybrook Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant and agree to use birth control during and for 40 days after treatment.I have been diagnosed with bleeding in the back of my eye.I have choroidal effusions but haven't had glaucoma surgery.My eye condition improved with treatment within a week.I refuse to receive injections behind my eye.I am showing signs of an infection.I am over 18 years old.I had glaucoma surgery and my condition didn't improve after a week of standard treatment.I have aqueous misdirection and my eye pressure is above 10 mmHg.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Injection
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor enrolling participants at the moment?
"Affirmative. Per the information available on clinicaltrials.gov, this medical study is currently looking for volunteers and was first posted on October 14th 2020. The trial seeks to enrol 20 individuals from a single site."
Answered by AI
To what extent is this experiment populated by participants?
"Affirmative. According to clinicaltrials.gov, recruitment for this trial is currently in progress and began on October 14th 2020. The study was last updated on May 3rd 2022 and requires the enrollment of 20 patients from a single site."
Answered by AI
What sort of health risks does administering injections pose to individuals?
"Our team determined that the injection has an elevated standard of safety, warranting a rating of 3. This is because the treatment has already been authorised in Phase 4 trials."
Answered by AI
For what medical conditions is injection typically prescribed?
"Injection is a suitable treatment for ulcerative colitis, hand-related issues, and brain ailments."
Answered by AI
Could you elaborate on any other experiments involving Injection that have taken place?
"Currently, 41 clinical trials are ongoing to explore the efficacy of Injection and 8 of those studies have reached phase 3. Although most sites are located in Columbia, Missouri; a total 75 locations around the world are researching this therapy."
Answered by AI
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