GlaucomaPhase 4TRICEPSNCT02917564
Triamcinolone Injections for Persistent Choroidal Effusions Post Glaucoma Surgery
A Phase 4 study testing Triamcinolone Acetonide 1 ml of 40 mg/mL suspension in people with Glaucoma and Choroidal Effusions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Choroidal Effusions
- What is being tested?
- Triamcinolone Acetonide 1 ml of 40 mg/mL suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2020to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Catherine M Birt, MD FRCSC, 416 480-5882, catherine.birt@sunnybrook.ca
Catherine M Birt, MD FRCSC
About this study
Official title: Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery
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.
Read the 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.
- Conditions
- Glaucoma, Choroidal Effusions
- Being tested
- Triamcinolone Acetonide 1 ml of 40 mg/mL suspension, Sham - Participants will not recieve the Triamcinolone Acetonide
- Keywords
- Choroidal effusions, Trabeculectomy
- Medical subject headings
- Glaucoma, Choroidal Effusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 1 ml of 40 mg/mL suspensionDrug
Also called Kenalog
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 AcetonideOther
Patients will be given a sham.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution
The time to clinical resolution of the choroidal effusions will be determined
Measured: One week to three months
Secondary outcomes (4)
IOP
Intraocular pressure at the final study visit
Measured: 3 month visit
Vision
Visual acuity at the final study visit
Measured: 3 month visit
Medications
Number of glaucoma medications required at the final study visit
Measured: 3 month visit
Complications
Any intra-operative or post-procedural side effects or complications, including further surgery, will be recorded and compared between the two groups
Measured: All study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start14 Oct 2020
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Catherine Birt, Sunnybrook Health Sciences Centre
- Investigators
- Catherine M Birt, MD FRCSC, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917564
- Sponsor's protocol ID
- 474-2015
- Acronym
- TRICEPS
- Status last verified
- May 2022
- First submitted
- 23 Sep 2016
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Summary data will be reported, individual participant data will not
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subtenons Triamcinolone Acetonide Injections for Treatment of Persistent Choroidal Effusions Post Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT02917564
- Acronym / sponsor ID
- TRICEPS / 474-2015
- Conditions
- Glaucoma, Choroidal Effusions
- Keywords
- Choroidal effusions, Trabeculectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Sham - Participants will not recieve the Triamcinolone AcetonidePatients 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. |
| Injection | Active comparator | Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspensionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Acetonide 1 ml of 40 mg/mL suspensionAlso: KenalogAfter 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. | Drug | Injection |
| Sham - Participants will not recieve the Triamcinolone AcetonidePatients will be given a sham. | Other | Control |
Primary outcome
Time to resolution
Time frame: One week to three months
The time to clinical resolution of the choroidal effusions will be determined
4 secondary outcomes
IOP
Time frame: 3 month visit
Vision
Time frame: 3 month visit
Medications
Time frame: 3 month visit
Complications
Time frame: All study visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided. Summary data will be reported, individual participant data will not
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine M Birt, MD FRCSC principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Acetonide 1 ml of 40 mg/mL suspension in people with Glaucoma and Choroidal Effusions, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine M Birt, MD FRCSC (416-480-5882, catherine.birt@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution (time frame: One week to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.