ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12615000307505

Ethics application status

Approved

Date submitted

10/03/2015

Date registered

1/04/2015

Date last updated

25/07/2019

Date data sharing statement initially provided

25/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Systematic glaucoma screening and diagnostic effectiveness: can early detection improve patient outcomes?

Scientific title

For glaucoma patients and suspects, does better diagnostic effectiveness of the referring optometrist result in improved outcomes?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1167-9629

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

Public Health

Health promotion/education

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

Patients at risk, suspects or monitored for glaucoma will be followed over a 5 year period. Biannual exams as recommended by the "NHMRC guidelines for the screening, prognosis, diagnosis, management and prevention of glaucoma 2010" will be performed and results will be compared to an age-related control group. Exams include patient history, refraction, slit lamp exam, visual field test (SAP), Gonioscopy, Pachymetry, OCT scan, HRT, and optic disc photography.

Intervention code [1]

Not applicable

Comparator / control treatment

Patients with no or low risk of developing glaucoma or age-matched patients with other common eye disorders, such as age-related macular degeneration, monitored and managed according to standard clinical care will serve as control. Control patients will be monitored for at least 2 years or until 5 exams have been obtained.

Control group

Active

Outcomes

Primary outcome [1]

Diagnostic accuracy measured as the proportion of true positive referrals defined as those patients referred as glaucoma suspects or with suggested glaucomatous changes that are confirmed during examination.

Timepoint [1]

five years

Secondary outcome [1]

Predictors for earlier diagnosis defined as exam outcomes that show a better correlation with the determined patient glaucoma status than the primary outcome. Multivariate regression models will be applied to identify those exam outcomes that result in the best prediction of the patient disease status at the study end point.

Timepoint [1]

5 years

Eligibility

Key inclusion criteria

Inclusion criteria: 18-80 year, gonioscopically open angles, IOP below 32 in either eye, normal optic disc at initial clinical examination and on stereoscopic photographs as determined by the two independent ophthalmologists with specialty in glaucoma, 2 normal and reliable visual field tests per eye at initial examination as determined by the two independent ophthalmologists with specialty in glaucoma.

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Glaucoma other than primary open angle glaucoma, previous intraocular surgery (other than uncomplicated cataract extraction with posterior chamber lens implantation), and any disases capable of causing visual field loss or optic disc deterioration.

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Both

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

30/10/2012

Date of last participant enrolment

Anticipated

Actual

18/08/2017

Date of last data collection

Anticipated

Actual

19/07/2019

Sample size

Target

1500

Accrual to date

Final

361

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Michael Kalloniatis

Address

Centre for Eye Health
UNSW Australia
Ruperts Myers building (south wing)
Barker St, Gate 14
Kensington NSW 2052

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Guide Dogs NSW/ACT

Address [1]

2-4 Thomas Street
Chatswood NSW 2067

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Reserach Ethis Advisory Panel 'H', Science and Engineering UNSW Australia

Ethics committee address [1]

UNSW Australia
Sydney NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/04/2012

Ethics approval number [1]

08/2014/36

Ethics committee name [2]

Human Reserach Ethis Advisory Panel 'H', Science and Engineering UNSW Australia

Ethics committee address [2]

UNSW Australia
Sydney NSW 2052

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/08/2014

Ethics approval number [2]

08/2014/37

Summary

Brief summary

In Australia ~75% of eye examinations are delivered by Optometrists.  Optometrists have a legal and moral obligation to identify eye disease, manage suitable cases and refer others requiring medical or surgical intervention to ophthalmologists.
With an aging population, the management of chronic eye disease is an increasing issue for the already stretched health system.  The NHMRC glaucoma guidelines encourage development of shared-care models between primary health care providers and ophthalmologists. The guidelines also highlight the need for low-risk glaucoma patients to be monitored by primary eye care providers and not referred to Ophthalmology thereby minimizing the possibility that the health system is overloaded with false positive referrals.
Until now, this new model of glaucoma management has been largely unexplored, especially with regards to assessing the effectiveness of the current optometric profession in clinical diagnosis, referral quality, appropriately utilization of new technologies and integrating with complementary facilities and services.
The Centre for Eye Health (CFEH), a joint Guide Dogs NSW/ACT and UNSW initiative is leading the way in promoting a shared care model for eye-care in Australia. Ophthalmic practitioners refer patients to CFEH for visual assessment using the latest technology. Over 830 optometrists in NSW/ACT have registered with CFEH. It is proposed that this pool of participants be analysed with regards to current glaucoma practice characteristics, effectiveness in clinical diagnosis, referral quality, appropriate utilisation of new technologies and integration with complementary facilities and services. 
The research will inform current models of Glaucoma management and the evidence will have direct policy implications for the regulatory partners.  Ultimately, more cohesive and patient-focused service delivery will lead to improved quality of life for patients and a reduced economic burden of eye disease nationally.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Michael Kalloniatis

Address

Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0710

Fax

MKalloniatis@cfeh.com.au

Contact person for public queries

Name

Michael Kalloniatis

Address

Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0710

Fax

MKalloniatis@cfeh.com.au

Contact person for scientific queries

Name

Michael Kalloniatis

Address

Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052

Country

Australia

Phone

+61 2 8115 0710

Fax

MKalloniatis@cfeh.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

This project was approved for the publication of summary data. Individual participant data will not be published to protect the anonymity of individual patients.

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.

Trial Review

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