Triamcinolone Injections for Choroidal Effusions Post Glaucoma Surgery

(TRICEPS Trial)

Overseen By Cindy Rutz

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Choroidal hemorrhage, Aqueous misdirection, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

During glaucoma surgery, a new opening is created that allows fluid to drain out of the eye, bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. In some patients who have had glaucoma surgery too much fluid flows out and this results in a pressure that is too low. This may cause swelling of one layer at the back of the eye called the choroid. The formation of this swelling, called a choroidal effusion or "choroidal", often makes the eye pressure stay too low, and one of the results is a decrease in vision. The treatment for a choroidal effusion is to try to raise the eye pressure somewhat to allow the swelling to subside. In our clinical work, we have found that an injection with an anti-inflammatory drug called triamcinolone appears to be helpful in speeding up healing. We plan to compare two groups of patients with choroidal effusions, one group that gets an injection of triamcinolone and one that gets a "sham" treatment with nothing injected and compare the length of time it takes the choroidal effusions to disappear. Both groups receive the standard treatment with eye drops. We will also assess the outcome of the glaucoma surgery and any other complications that may occur. This research is aimed at studying a new method of improving the outcomes of surgery for glaucoma patients, and further the treatment of glaucoma.

Research Team

Catherine M Birt, MD FRCSC

Principal Investigator

Sunnybrook Research Institute

Eligibility Criteria

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.

Inclusion Criteria

Decision makers fluent in English

I am over 18 years old.

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

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a triamcinolone injection or a sham treatment, followed by topical prednisolone acetate 1% for 4 weeks

4 weeks

1 visit (in-person) for injection, followed by weekly monitoring

Follow-up

Participants are monitored for resolution of choroidal effusions, intraocular pressure, visual acuity, and any complications

3 months

Monthly visits (in-person)

Treatment Details

Interventions

• Triamcinolone Acetonide

Trial Overview 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.

Participant Groups

Group I: Injection Active Control 1 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: Control Placebo Group 1 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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+