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Trial registered on ANZCTR


Registration number
ACTRN12611001191987
Ethics application status
Approved
Date submitted
14/11/2011
Date registered
17/11/2011
Date last updated
14/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Predicting Glaucoma Progression Project
Scientific title
A study to examine the utility of an Ibopamine challenge test, to differentiate glaucoma patients whose disease is progressively worsening from those whose disease is stable.
Secondary ID [1] 273390 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 279167 0
Condition category
Condition code
Eye 279362 279362 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraocular pressure (IOP) is dependent on the balance between the production of aqueous fluid within the eye and the rate at which aqueous leaves the eye through the trabecular meshwork (TM) in the angle of the eye’s anterior chamber. The medication Ibopamine (Trazyl: Pharmainvest SpA, Milano, Italy) which is a dopamine receptor agonist, will temporarily increase aqueous production and dilate the pupil. A healthy eye with healthy TM cells will overcome this increase, pump aqueous out of the eye at an increased rated and the patient will demonstrate no IOP rise when Ibopamine drops are applied topically to the eye, however there is evidence that those with glaucoma will exhibit a rise in IOP. It may be that patients whose glaucoma is progressively worsening, will demonstrate a larger increase in IOP when Ibopamine drops are applied topically to their eye compared with stable patients.
To undertake an Ibopamine challenge, the patient has their IOP measured and recorded using goldmann applanation tonometry seated at the slit lamp; they then had two drops of Ibopamine 2% solution instilled into their eye; lastly their IOP is re-measured 45 minutes after receiving the Ibopamine eye drops and the IOP results pre and post the challenge are compared.
Intervention code [1] 283722 0
Diagnosis / Prognosis
Intervention code [2] 283736 0
Early detection / Screening
Comparator / control treatment
Cases will be patients who have glaucoma which has historically been found to be progressing. Controls will be those whose glaucoma has been found to be stable. Both groups will receive the Ibopamine challenge and their results will be compared.
Control group
Active

Outcomes
Primary outcome [1] 285952 0
Intraocular pressure will be measured with the patient seated at the slit lamp using a goldmann applanation tonometer prior to and following the Ibopamine challenge. The test will be scored as either positive or negative. A positive challenge will be one in which the intraocular pressure has risen by at least 3 mmHg following the challenge. The proportion of those with a positive challenge will be compared between the group whose glaucoma has progressively worsened and the group whose glaucoma is stable.
Timepoint [1] 285952 0
45 minutes following the Ibopamine challenge test.
Secondary outcome [1] 294842 0
Intraocular pressure will be measured with the patient seated at the slit lamp using a goldmann applanation tonometer prior to and following the Ibopamine challenge. The difference between pre and post challenge intraocular pressure will be compared between the group whose glaucoma has progressively worsened and the group whose glaucoma is stable.
Timepoint [1] 294842 0
45 minutes following the Ibopamine challenge test.

Eligibility
Key inclusion criteria
Primary open angle glaucoma (POAG) as defined by: characteristic and corresponding visual field and optic disc findings which are consistent with glaucoma and an intraocular pressure on treatment of at least 20% less than that prior to treatment. Progression is based on a worsening of visual field loss on three consecutive visual field tests performed over at least the preceding 24 months. Stability is based on a stable visual field on at least three consecutive visual field tests performed over the preceding 24 months.
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: those with forms of glaucoma other than POAG (e.g angle-closure glaucoma, secondary glaucoma etc.), those who have undergone previous intraocular surgery (except cataract surgery), those who were unable to perform a reliable visual field test and those who were unable to give informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Both cases and controls would be selected from those attending the Flinders Medical Centre and the Repatriation General Hospital eye outpatients department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3232 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 9013 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 284205 0
Self funded/Unfunded
Name [1] 284205 0
John Landers
Address [1] 284205 0
The Flinders Medical Centre
BEDFORD PARK 5042
South Australia
Country [1] 284205 0
Australia
Primary sponsor type
Individual
Name
John Landers
Address
The Flinders Medical Centre
BEDFORD PARK 5042
South Australia
Country
Australia
Secondary sponsor category [1] 269162 0
None
Name [1] 269162 0
Address [1] 269162 0
Country [1] 269162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286166 0
the Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 286166 0
Ethics committee country [1] 286166 0
Date submitted for ethics approval [1] 286166 0
18/11/2011
Approval date [1] 286166 0
22/12/2011
Ethics approval number [1] 286166 0

Summary
Brief summary
Glaucoma is a blinding eye disease which can be treated by lowering eye pressure, or intraocular pressure (IOP). However some patients continue to get worse despite having an acceptably lowered IOP.
IOP is determined by the production of aqueous fluid within the eye and the rate at which aqueous leaves the eye through the trabecular meshwork (TM). The eye-drop medication Ibopamine which temporarily increases aqueous production, has no effect on normal patients; however those with glaucoma will exhibit a rise in IOP when Ibopamine is applied. Possibly, patients whose glaucoma is progressively worsening despite having a low IOP measured in the clinic will demonstrate a larger increase in IOP with Ibopamine drops.
We would like to recruit two groups of patients: one with glaucoma which is progressively deteriorating despite lowered IOP and one with stable glaucoma. We would then like to compare the change in their IOP when Ibopamine drops are applied to their eyes. Our aim is to validate this as a new test to predict which glaucoma patients will progress.
Trial website
Trial related presentations / publications
Ullrich K, Craig JE, Landers J. Ibopamine challenge test can be used to differentiate glaucoma suspects from glaucoma patients. Clin Exp Ophthalmol. 2014; 42: 342-6

Landers J, Ullrich K, Craig JE. Ibopamine challenge testing differentiates glaucoma suspect, stable glaucoma and progressive glaucoma cases. Clin Exp Ophthalmol. Published Online First: 3 July 2015. DOI 10.1111/ceo.12569
Public notes

Contacts
Principal investigator
Name 33391 0
A/Prof John Landers
Address 33391 0
Department of Ophthalmology
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK 5042
South Australia
Country 33391 0
Australia
Phone 33391 0
(+618) 8204 4219
Fax 33391 0
Email 33391 0
john.landers@bigpond.com
Contact person for public queries
Name 16638 0
A/Prof John Landers
Address 16638 0
The Flinders Medical Centre
BEDFORD PARK 5042
South Australia
Country 16638 0
Australia
Phone 16638 0
(+618) 8204 4219
Fax 16638 0
Email 16638 0
john.landers@bigpond.com
Contact person for scientific queries
Name 7566 0
A/Prof John Landers
Address 7566 0
The Flinders Medical Centre
BEDFORD PARK 5042
South Australia
Country 7566 0
Australia
Phone 7566 0
(+618) 8204 4219
Fax 7566 0
Email 7566 0
john.landers@bigpond.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary