Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000767505
Ethics application status
Not yet submitted
Date submitted
28/11/2014
Date registered
24/07/2015
Date last updated
24/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Predicting Glaucoma Development Project: Examining the utility of an Ibopamine challenge test to predict glaucoma development in glaucoma suspects.
Scientific title
A study to examine the utility of an Ibopamine challenge test, to predict who might develop glaucoma from those patients who are glaucoma suspects.
Secondary ID [1] 285755 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 293642 0
Condition category
Condition code
Eye 293938 293938 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 rate 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 both of their eyes; 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] 290717 0
Early detection / Screening
Intervention code [2] 290718 0
Diagnosis / Prognosis
Comparator / control treatment
This will be a longitudinal cohort study of those who are glaucoma suspects. The entire group will receive the ibopamine challenge. Then they will be followed. At the end of the follow-up period, the results of the ibopamine challenge will be compared with the outcome of the glaucoma suspects to determine the ability of the ibopamine challenge to predict glaucoma development.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293714 0
The development of a glaucomatous visual field defect using the Humphrey Visual Field Analyzer.
Timepoint [1] 293714 0
2 years following the administration of the ibopamine challenge
Secondary outcome [1] 311648 0
Development of a nerve fibre layer defect using Zeiss Cirrus Optical Coherence Tomography.
Timepoint [1] 311648 0
2 years following the administration of the ibopamine challenge

Eligibility
Key inclusion criteria
Inclusion criteria for glaucoma suspects will be: an elevated IOP above 21 mmHg or an optic nerve head whose parameters are highly suspicious and resembling glaucoma. Patients will need to have a normal visual field test and therefore not have glaucoma at the time of entry into the study.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: those with secondary glaucoma, 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)
Glaucoma suspects will 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
Longitudinal cohort study
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3227 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 9005 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 290324 0
Government body
Name [1] 290324 0
South Australian Science Excellence Award: Early Career STEM Professional
Country [1] 290324 0
Australia
Primary sponsor type
Individual
Name
John Landers
Address
The Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK 5042
South Australia
Country
Australia
Secondary sponsor category [1] 289042 0
None
Name [1] 289042 0
Address [1] 289042 0
Country [1] 289042 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292034 0
the Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 292034 0
Southern Adelaide Health Service
Room 2A221 - Inside Human Resources
Flinders Medical Centre, 1 Flinders Drive Bedford Park SA 5042
Ethics committee country [1] 292034 0
Australia
Date submitted for ethics approval [1] 292034 0
08/12/2014
Approval date [1] 292034 0
Ethics approval number [1] 292034 0

Summary
Brief summary
It’s a clinical trial of a drug called Ibopamine, to be used in a challenge test in much the same way as a water drinking test. Ibopamine is an alpha, beta and dopamine receptor agonist, which causes a brief increase in aqueous production for about 4 hours after a single drop. Among normal patients, this causes no change in intraocular pressure, but in glaucoma patients, IOP will increase. My suspicion is that the degree of IOP rise might be related to the patient’s likelihood of further progression in the future. I have recently completed a pilot case-control study which has successfully shown that an ibopamine challenge can differentiate between glaucoma suspects, stable glaucoma patients and patients whose glaucoma is rapidly worsening. Now, I would like to commence a longitudinal study investigating the predictive value of a positive ibopamine challenge among glaucoma suspects and early glaucoma patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53138 0
A/Prof John Landers
Address 53138 0
The Flinders Medical Centre 1 Flinders Drive BEDFORD PARK 5042 South Australia
Country 53138 0
Australia
Phone 53138 0
(+618) 8204 4219
Fax 53138 0
Email 53138 0
[email protected]
Contact person for public queries
Name 53139 0
A/Prof John Landers
Address 53139 0
The Flinders Medical Centre 1 Flinders Drive BEDFORD PARK 5042 South Australia
Country 53139 0
Australia
Phone 53139 0
(+618) 8204 4219
Fax 53139 0
Email 53139 0
[email protected]
Contact person for scientific queries
Name 53140 0
A/Prof John Landers
Address 53140 0
The Flinders Medical Centre 1 Flinders Drive BEDFORD PARK 5042 South Australia
Country 53140 0
Australia
Phone 53140 0
(+618) 8204 4219
Fax 53140 0
Email 53140 0
(+618) 8204 4219

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.