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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)

Must not have

Patients with choroidal hemorrhage, demonstrated clinically and or with B Scan

Patients with choroidal effusions who did not have glaucoma surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month visit

Awards & highlights

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I had glaucoma surgery and my condition didn't improve after a week of standard treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with bleeding in the back of my eye.

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I have choroidal effusions but haven't had glaucoma surgery.

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I refuse to receive injections behind my eye.

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I have aqueous misdirection and my eye pressure is above 10 mmHg.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week to three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to resolution

Secondary study objectives

Complications

IOP

Medications

+1 more

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

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

0 / 6Eligibility criteria met