- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917564
Triamcinolone Injections for Persistent Choroidal Effusions Post Glaucoma Surgery (TRICEPS)
Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery
Study Overview
Status
Conditions
Detailed Description
Glaucoma is the second commonest cause of blindness in our society. The only effective treatment currently involves lowering the intraocular pressure (IOP) by medical, laser, or surgical techniques. Glaucoma surgery is indicated when further IOP lowering is needed despite maximal medical therapy and appropriate laser treatment.
The choroid is a pigmented and vascular structure located between the sclera and retinal pigmented epithelium.
Choroidal effusions are aberrant collections of fluid within the suprachoroidal potential space. There are two types of choroidal effusion, serous and hemorrhagic, depending on the type of fluid that accumulates in the suprachoroidal space. A serous choroidal effusion is composed of a transudate fluid from increased transmural pressure across the capillaries. Their development is usually relatively painless. Hemorrhagic choroidal effusion or suprachoroidal haemorrhage is a sudden and usually very painful accumulation of blood in the suprachoroidal space. 4 Choroidal effusions can be caused by both low IOP and pro-inflammatory conditions. Causes of concomitant low IOP and inflammation include trauma and eye surgery, especially glaucoma surgery. Inflammatory causes include scleritis.
Modern glaucoma surgery has minimized the incidence of postoperative hypotony and resultant choroidal effusion but it is still prevalent. 1 The prevalence of choroidal effusions after glaucoma surgery varies between 10 and 15%, with average of 13% after trabeculectomy (the standard technique of glaucoma surgery). 5 A complication of low-IOP-induced choroidal effusion is hypotony maculopathy, which can cause permanent decline in vision, especially if not resolved in a timely manner. 5 Treatment can be either medical or surgical. Medical treatment includes cessation of any systemic and topical IOP lowering agents and adding cycloplegic agents, topical steroids and eventually systemic steroids. If treatments do not increase the IOP and reduce the choroidal effusion, then surgical management should be considered.
Depending on the particular clinical circumstances of each patient, different surgical approaches can be used, including revision of the trabeculectomy flap, anterior chamber reformation, and surgical drainage of the effusion.
As an alternative to systemic steroids, steroids as triamcinolone acetonide (Kenalog™) can be injected in the subtenons space. This treatment allows for a high local dose of steroids, without exposing the patient to systemic treatment. Not every patient requires steroid injection, and this treatment will be reserved for patients who do not respond to medical management after a few days.
Following the sham or Kenalog injection participants will receive topical prednisolone acetate 1% qid for 4 weeks or PRN Topical atropine 1% qid for one week or PRN.
There are several studies in the literature showing the benefit of a triamcinolone injection for different inflammatory conditions, such uveitis and for the treatment of diabetic maculopaty and cystoid macular edema. 6-9 Recently Shen et al. published the benefit of subtenons triamcinolone acetonide in the management of a combination of retinal detachment and choroidal effusion. 2 However we did not find any studies that assessed the benefit on triamcinolone subtenons injection for choroidal effusion after glaucoma surgery. In a recent retrospective study we performed a chart review of the effect of subtenons triamcinolone injection in patients with choroidal effusions after glaucoma surgery compared to a group of patients who did not receive the injection as part of their management. We found that recovery time in the injection group was significantly shorter than in patients with no injection, 10.6 days versus 27.44 days. (p=0.02). The study showed no difference in final intraocular pressure (IOP), number of medications and visual acuity.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Catherine M Birt, MD FRCSC
- Phone Number: 416-480-5882
- Email: catherine.birt@sunnybrook.ca
Study Contact Backup
- Name: Cindy Rutz
- Phone Number: 416-480-5091
- Email: cindy.rutz@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Research Institute
-
Contact:
- Catherine M Birt, MD FRCSC
- Phone Number: 416 480-5882
- Email: catherine.birt@sunnybrook.ca
-
Principal Investigator:
- Catherine M Birt, MD FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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. |
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. |
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to resolution
Time Frame: One week to three months
|
The time to clinical resolution of the choroidal effusions will be determined
|
One week to three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IOP
Time Frame: 3 month visit
|
Intraocular pressure at the final study visit
|
3 month visit
|
Vision
Time Frame: 3 month visit
|
Visual acuity at the final study visit
|
3 month visit
|
Medications
Time Frame: 3 month visit
|
Number of glaucoma medications required at the final study visit
|
3 month visit
|
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
|
All study visits
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine M Birt, MD FRCSC, Sunnybrook Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Eye Abnormalities
- Uveal Diseases
- Choroid Diseases
- Glaucoma
- Choroidal Effusions
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 474-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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