Recruiting

Triamcinolone Injections

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02917564

Conditions

Glaucoma

Choroidal Effusions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Acetonide 1 ml of 40 mg/mL suspension

Sham - Participants will not recieve the Triamcinolone Acetonide

Study Details

Brief summary:

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.

Conditions

Glaucoma

Choroidal Effusions

Study ID

NCT02917564

Start date

Oct 14, 2020

Status verified date

May, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

May 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Decision makers fluent in English.
  • Decision makers able to understand and read consent form.

Exclusion Criteria:

  • Patients with choroidal effusions with improvement after one week of medical treatment.
  • Patients with choroidal hemorrhage, demonstrated clinically and or with B Scan.
  • Patients with aqueous misdirection and IOP > 10 mmHg.
  • Patients that refuse subtenons injection.
  • Patients with signs of infection.
  • Patients with choroidal effusions who did not have glaucoma surgery.
  • Patients unable to follow up within study schedule.
  • Female patients of childbearing potential who are pregnant of do not agree to use adequate methods of contraception from time of enrollment until 40 days after the last day of Triamcinolone administration.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Control

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.

active comparator: Injection

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.

Interventions

Triamcinolone Acetonide 1 ml of 40 mg/mL suspension

After preparation, Triamcinolone Acetonide 1 ml of 40 mg/mL suspension 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.

Sham - Participants will not recieve the Triamcinolone Acetonide

Patients will be given a sham.

Primary outcome measure

  • Time to resolution [ Time Frame: One week to three months ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Catherine M Birt, MD FRCSC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 4, 2022

Last verified

May, 2022

Keywords

  • Choroidal effusions
  • Trabeculectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2022-05-04.