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Trial record 19 of 927 for:    triamcinolone acetonide

Triamcinolone Injections for Persistent Choroidal Effusions Post Glaucoma Surgery (TRICEPS)

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ClinicalTrials.gov Identifier: NCT02917564
Recruitment Status : Not yet recruiting
First Posted : September 28, 2016
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Catherine Birt, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Glaucoma Choroidal Effusions Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension Other: Sham - Participants will not recieve the Triamcinolone Acetonide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
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.

Other: Sham - Participants will not recieve the Triamcinolone Acetonide
Patients will be given a sham.

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.

Drug: 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.
Other Name: Kenalog




Primary Outcome Measures :
  1. Time to resolution [ Time Frame: One week to three months ]
    The time to clinical resolution of the choroidal effusions will be determined


Secondary Outcome Measures :
  1. IOP [ Time Frame: 3 month visit ]
    Intraocular pressure at the final study visit

  2. Vision [ Time Frame: 3 month visit ]
    Visual acuity at the final study visit

  3. Medications [ Time Frame: 3 month visit ]
    Number of glaucoma medications required at the final study visit

  4. Complications [ Time Frame: All study visits ]
    Any intra-operative or post-procedural side effects or complications, including further surgery, will be recorded and compared between the two groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02917564


Contacts
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Contact: Catherine M Birt, MD 4164670671 catherine.birt@sunnybrook.ca
Contact: Charlene Muller, RN 4164805091 charlene.muller@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Catherine M Birt, MD FRCSC    416 480-5882    catherine.birt@sunnybrook.ca   
Principal Investigator: Catherine M Birt, MD FRCSC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Catherine Birt, Ophthalmologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02917564     History of Changes
Other Study ID Numbers: 474-2015
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Summary data will be reported, individual participant data will not

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Catherine Birt, Sunnybrook Health Sciences Centre:
Choroidal effusions
Trabeculectomy
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Glaucoma
Ocular Hypertension
Eye Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action