ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Glaucoma

Condition category

Condition code

Eye

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]

Diagnosis / Prognosis

Intervention code [2]

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]

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]

45 minutes following the Ibopamine challenge test.

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/12/2011

Actual

2/07/2012

Date of last participant enrolment

Anticipated

Actual

29/07/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

John Landers

Address [1]

The Flinders Medical Centre
BEDFORD PARK 5042
South Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

John Landers

Address

The Flinders Medical Centre
BEDFORD PARK 5042
South Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

the Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

18/11/2011

Approval date [1]

22/12/2011

Ethics approval number [1]

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

A/Prof John Landers

Address

Department of Ophthalmology
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK 5042
South Australia

Country

Australia

Phone

(+618) 8204 4219

Fax

john.landers@bigpond.com

Contact person for public queries

Name

John Landers

Address

The Flinders Medical Centre
BEDFORD PARK 5042
South Australia

Country

Australia

Phone

(+618) 8204 4219

Fax

john.landers@bigpond.com

Contact person for scientific queries

Name

John Landers

Address

The Flinders Medical Centre
BEDFORD PARK 5042
South Australia

Country

Australia

Phone

(+618) 8204 4219

Fax

john.landers@bigpond.com

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

Source	Title	Year of Publication	DOI
Embase	Ibopamine challenge testing differentiates glaucoma suspect, stable glaucoma and progressive glaucoma cases.	2015	https://dx.doi.org/10.1111/ceo.12569
Embase	Ibopamine challenge testing becomes negative following successful trabeculectomy surgery.	2016	https://dx.doi.org/10.1111/ceo.12684

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically