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Trial registered on ANZCTR


Registration number
ACTRN12611000336987
Ethics application status
Approved
Date submitted
30/03/2011
Date registered
31/03/2011
Date last updated
29/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective study into the effect of an intraocular injection of a steroid in the prevention of Glaucoma drainage surgery failure after cataract surgery
Scientific title
Prospective randomised trial of intravitreal triamcinolone in the prevention of trabeculectomy failure after cataract surgery
Secondary ID [1] 259882 0
Nil
Universal Trial Number (UTN)
U1111-1120-4139
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 265474 0
Glaucoma filtration surgery failure after cataract surgery 265475 0
Condition category
Condition code
Eye 265628 265628 0 0
Diseases / disorders of the eye
Surgery 265635 265635 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single injection of intravitreal injection of Triamcinolone acetonide (4mg in 0.1ml) in conjunction with 5-Fluorouracil (5mg in 0.1ml) injected superior to the Glaucoma filtration bleb
Intervention code [1] 264305 0
Treatment: Drugs
Intervention code [2] 264312 0
Prevention
Comparator / control treatment
5-Fluorouracil injected superior to the glaucoma filtration bleb
Control group
Active

Outcomes
Primary outcome [1] 262414 0
Percentage of participants with intraocular pressure (IOP) >6mmHg - <18mmHg with no glaucoma medications at 12 months post injection.
This will be assessed using Goldmann applanation tonometry
Timepoint [1] 262414 0
12 months
Secondary outcome [1] 273736 0
IOP >6mmmHg<21mmHg with or without topical IOP lowering medication.
Timepoint [1] 273736 0
12 months
Secondary outcome [2] 273737 0
Bleb vascularity and morphology (graded by masked observer according to Moorfields bleb grading scheme 3)
Timepoint [2] 273737 0
12 months
Secondary outcome [3] 273738 0
Number of post-operative 5-FU injections
This will be assessed by data linkage to patient medical records
Timepoint [3] 273738 0
12 months

Eligibility
Key inclusion criteria
Patients with a functioning glaucoma filtration bleb who are due to undergo cataract surgery with intra-ocular lens implantation.
Minimum age
40 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active or recent bleb leak, known hypersensitivity to 5-FU or Triamcinolone, only eye, active or recent blebitis or endophthalmitis.Previous vitrectomy. Previous retinal detachment or tear. Inability to give informed consent. Inability to be safely administeedr an intravitreal injection.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer randomisation at time of enrollment into trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Combination of safety and efficacy
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264768 0
Hospital
Name [1] 264768 0
Royal Victorian Eye and Ear
Country [1] 264768 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear
Address
32 Gisborne Street
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 263885 0
None
Name [1] 263885 0
Address [1] 263885 0
Country [1] 263885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266745 0
Ethics committee address [1] 266745 0
Ethics committee country [1] 266745 0
Australia
Date submitted for ethics approval [1] 266745 0
11/04/2011
Approval date [1] 266745 0
Ethics approval number [1] 266745 0

Summary
Brief summary
Trabeculectomy surgery for Glaucoma establishes a connection between the inside of the eye and the subconjunctival space which lies just below the surface of the eye. Flow of fluid through this connection forms a subconjunctival blister known as a bleb. Aqueous humor (fluid inside the front of the eye )is absorbed from the bleb into the blood stream.

A significant casue of failure of trabeculectomy is scarring of the bleb. If the bleb develops an excessive amount of scar tissue then fluid is prevented from exiting and the eye pressure is increased. Cataract surgery has been shown in research trials to increase the risk of trabeculectomy failure.

Control of postoperative scar formation after cataract surgery is a significant challenge in the surgical management of glaucoma in patients who have had previous Trabeculectomy surgery. Current practice is to use topical steroids and antiscarring agents such as 5-fluorouracil (5-FU). Although the use of 5-FU is widespread, scar tissue remains a problem in many patients and treatment is associated with side effects including wound leaks and disruption of the ocular surface.

Active scarring is associated with inflammation. Triamcinolone is a synthetic corticosteroid that inhibits the inflammatory process and may therefore reduce scar formation. Injection of triamcinolone into the vitreous jelly of the eye has been widely used as a treatment for various diabetic and inflammatory conditions which are unresponsive to topical corticosteroids. It has been used as a mono-therapy and co-therapy for various back of eye conditions, and is also indicated for visualisation during vitrectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32409 0
Address 32409 0
Country 32409 0
Phone 32409 0
Fax 32409 0
Email 32409 0
Contact person for public queries
Name 15656 0
Dan Nguyen
Address 15656 0
Royal Victorian Eye & Ear Hospital
32 Gisborne Street
East Melbourne
VIC 3002
Country 15656 0
Australia
Phone 15656 0
+61 3 9929 8666
Fax 15656 0
Email 15656 0
[email protected]
Contact person for scientific queries
Name 6584 0
Dan Nguyen
Address 6584 0
Royal Victorian Eye & Ear Hospital
32 Gisborne Street
East Melbourne
VIC 3002
Country 6584 0
Australia
Phone 6584 0
+61 3 9929 8666
Fax 6584 0
Email 6584 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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