Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date results information 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] 286330 0
Nil
Universal Trial Number (UTN)
U1111-1167-9629
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 294439 0
Condition category
Condition code
Eye 294744 294744 0 0
Diseases / disorders of the eye
Public Health 294904 294904 0 0
Health promotion/education
Public Health 294905 294905 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
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] 291381 0
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] 294508 0
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] 294508 0
five years
Secondary outcome [1] 313491 0
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] 313491 0
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] 9360 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 290904 0
Government body
Name [1] 290904 0
National Health and Medical Research Council
Country [1] 290904 0
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] 289585 0
Charities/Societies/Foundations
Name [1] 289585 0
Guide Dogs NSW/ACT
Address [1] 289585 0
2-4 Thomas Street
Chatswood NSW 2067
Country [1] 289585 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292506 0
Human Reserach Ethis Advisory Panel 'H', Science and Engineering UNSW Australia
Ethics committee address [1] 292506 0
UNSW Australia
Sydney NSW 2052
Ethics committee country [1] 292506 0
Australia
Date submitted for ethics approval [1] 292506 0
Approval date [1] 292506 0
19/04/2012
Ethics approval number [1] 292506 0
08/2014/36
Ethics committee name [2] 292589 0
Human Reserach Ethis Advisory Panel 'H', Science and Engineering UNSW Australia
Ethics committee address [2] 292589 0
UNSW Australia
Sydney NSW 2052
Ethics committee country [2] 292589 0
Australia
Date submitted for ethics approval [2] 292589 0
Approval date [2] 292589 0
12/08/2014
Ethics approval number [2] 292589 0
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 55634 0
Prof Michael Kalloniatis
Address 55634 0
Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 55634 0
Australia
Phone 55634 0
+61 2 8115 0710
Fax 55634 0
Email 55634 0
[email protected]
Contact person for public queries
Name 55635 0
Prof Michael Kalloniatis
Address 55635 0
Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 55635 0
Australia
Phone 55635 0
+61 2 8115 0710
Fax 55635 0
Email 55635 0
[email protected]
Contact person for scientific queries
Name 55636 0
Prof Michael Kalloniatis
Address 55636 0
Centre for Eye Health
UNSW Australia
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 55636 0
Australia
Phone 55636 0
+61 2 8115 0710
Fax 55636 0
Email 55636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.