Triamcinolone Injections for Persistent Choroidal Effusions Post Glaucoma Surgery

NCT02917564 | Unknown Phase 4 DMC

• 1 other identifier: 474-2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Choroidal effusions; Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Time to resolution

  The time to clinical resolution of the choroidal effusions will be determined

  One week to three months

Secondary Outcomes (4)

• IOP

  3 month visit

• Vision

  3 month visit

• Medications

  3 month visit

• Complications

  All study visits

Study Arms (2)

Control

SHAM COMPARATOR

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.

Other: Sham - Participants will not recieve the Triamcinolone Acetonide

Injection

ACTIVE COMPARATOR

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.

Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension

Interventions

Triamcinolone Acetonide 1 ml of 40 mg/mL suspension DRUG

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.

Also known as: Kenalog

Injection

Sham - Participants will not recieve the Triamcinolone Acetonide OTHER

Patients will be given a sham.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma; Choroidal Effusions

Interventions

Triamcinolone Acetonide; Suspensions

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Eye Abnormalities; Choroid Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Catherine M Birt, MD FRCSC

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine M Birt, MD FRCSC

CONTACT

416-480-5882; catherine.birt@sunnybrook.ca

Cindy Rutz

CONTACT

416-480-5091; cindy.rutz@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 28, 2016
• Study Start: October 14, 2020
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2024
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

CA (1)