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Trial registered on ANZCTR


Registration number
ACTRN12615001274561
Ethics application status
Approved
Date submitted
19/11/2015
Date registered
23/11/2015
Date last updated
10/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Icare-HOME tonometer for patient self-monitoring of eye pressure to optimise glaucoma management
Scientific title
For glaucoma patients and suspects, does home self-monitoring for six weeks following the initial clinical assessment result in better clinical management decisions?
Secondary ID [1] 287936 0
Nil
Universal Trial Number (UTN)
U1111-1176-6813
Trial acronym
IGIS (Icare-home Glaucoma IOP Self-monitoring)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 296816 0
Condition category
Condition code
Eye 297045 297045 0 0
Diseases / disorders of the eye
Eye 297046 297046 0 0
Normal eye development and function
Public Health 297047 297047 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to being enrolled in the study, all patients will undergo a comprehensive glaucoma assessment and evaluation for inclusion and exclusion criteria. Patients who meet the study criteria, agree to participate, and provide written consent as outlined in the tenants of the declaration of Helsinki and approved by the ethics committee at UNSW Australia will be enrolled into the study. Assignment to the ICARE HOME monitoring group (=study group) or control group will be performed by a random number generator. All patients will undergo identical protocols other than the collection of ICARE HOME Intra-ocular pressure (IOP) measurements in the study group. This protocol will be executed until at least 30 patients have been assigned to the study group.
IOP data will be obtained for both eyes, for both clinical and research purposes. Subjects will be asked to measure their IOP at four time points during the day for 6 weeks: immediately upon awakening, before lunch, before dinner, and before going to bed. The patients will be asked to attempt to measure their IOP at the same time each day. The IOP and time of measurement is automatically recorded by ICARE HOME. A subset of the ‘glaucoma suspect’ group (n=10) will be asked to intensively measure their IOP over the first 48-hour period (upon awakening and every 2 hours during waking hours).

Patients will be trained in the use of the ICARE HOME device, a procedure that takes less than five minutes per measurement. After turning the instrument on, the patient will need to load a single-use probe into the tonometer without touching it and briefly (1 second) press the measure button. Subsequently, the probe tip needs to be aligned with the centre of the cornea, preferentially in front of a mirror, by placing the forehead and cheek support in the respective positions as indicated by the eye care professional during training. If placed correctly, the probe base light will appear green. Pressing the measure button will allow the probe to collect a total of 6 measurements within a matter of seconds. Measurements should then be repeated in the other eye. Once finished, the patient should turn off the instrument by pushing the power button until three short beeps are heard and discard the used probe.
Intervention code [1] 293286 0
Treatment: Devices
Intervention code [2] 293297 0
Early detection / Screening
Comparator / control treatment
The control group will undergo identical protocols for glaucoma management in alignment with traditional clinical care. IOP measurement will be taken during each clinical visit. Control group will not be asked to self-monitor in between visits.
Control group
Active

Outcomes
Primary outcome [1] 296646 0
Intra-ocular pressure (IOP) measured with the ICARE HOME device in the home environment in comparison to in-clinic measurements with traditional applanation tonometry.
Timepoint [1] 296646 0
6 weeks past study enrollment
Primary outcome [2] 296647 0
Effect of self-monitored IOP measurements on management decisions; Confirmation or adjustment of patient management will be determined during the follow-up visit and recorded before data from the ICARE HOME device are being made available to the clinician. Effect of the ICARE HOME IOP measurements will be recorded as any change in the decision after the data has been disclosed.
Timepoint [2] 296647 0
6 weeks past study enrollment
Secondary outcome [1] 318985 0
Compliance of the subjects with regards to using the ICARE HOME device. Compliance will be determined from date/time points automatically recorded by the ICARE HOME device.
Timepoint [1] 318985 0
6 weeks past study enrollment
Secondary outcome [2] 319070 0
Satisfaction of the subjects with regards to using the ICARE HOME device; Satisfaction of all participants will be determined with a modified PSQ-18 form to address care related to the ICARE HOME device included for the study group.
Timepoint [2] 319070 0
6 weeks past study enrollment

Eligibility
Key inclusion criteria
- Diagnosis of ‘glaucoma suspect’, including those being followed for elevated IOP, for risk factors for developing glaucoma, or for possible optic nerve damage.
- Diagnosis of ‘glaucoma’ where there is either confirmed optic nerve damage and/or visual field loss consistent with glaucomatous optic neuropathy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Uncorrected near visual acuity of 6/60 (N24) or worse
- Only one functional eye
- Poor or eccentric fixation in the study eye(s)
- Hearing impaired to the extent that the individual cannot hear and converse with others without an assistance aid and/or sign language
- High corneal astigmatism >3D in the study eye(s) based on autokeratometry
- Disabling arthritis or limited motor coordination limiting self-handling of the ICARE HOME tonometer
- Lack of comprehension or willingness to use the tonometer as instructed
- Corneal scarring
- History of prior incisional glaucoma surgery or cornea surgery, including corneal laser surgery
- Microphthalmos
- Buphthalmos
- Contact lens use
- Symptoms of dry eye syndrome and signs of dry eye on examination of the cornea
- Known history of difficulty in obtaining Goldmann IOP measurements or any factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or tremor)
- Nystagmus
- Keratoconus
- Any other corneal or conjunctival pathology or infection
- Inability to demonstrate proficiency with ICARE HOME tonometer after training and failure to complete certification procedures
- Cataract extraction within the last two months in the study eye(s)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
Based on a recent review of glaucoma patients referred to CFEH (n=89) we have to assume an average IOP of 19.04 (+/-3.6) mmHg for patients recruited for this study. Glaucoma treatment aims to reduce the patients IOP by 30%, thus providing an average target IOP for patients in this study of 13.33 mmHg. Clinical practice will generally accept variability of up to 2 mmHg. If the Icare HOME device would provide significant different information from conventional IOP measurements, it would have clinical impact if the difference was at least 3 mmHg. Therefore, sample size calculations were based on the detection of a difference between 13.33 and 16.33 mmHg assuming a standard deviation of 3.6 mmHg in both populations.

To accurately detect this difference with 90% power at a 5% significance level, we need 30 participants in each arm of the study. Based on preliminary results, the study may subsequently be extended to a larger sample set.

Data analysis:
Statistical analysis of the data will focus on changes in the IOP over the 6 week participation period. In the control group, the target IOP is conventionally calculated in relation to the baseline pressure. In the study group, linear regression models will be employed to calculate a modified target IOP from the ICARE HOME data. One-was ANOVA will be applied to identified significant differences between control and study group. In addition, two-way ANOVA analysis will be used to provide information on the influence of diurnal variation and time after treatment initiation on the estimation of appropriate target IOP and therefore glaucoma management.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/01/2016
Actual
3/02/2016
Date of last participant enrolment
Anticipated
21/12/2016
Actual
21/12/2016
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
60
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12264 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 292418 0
University
Name [1] 292418 0
UNSW Australia
Country [1] 292418 0
Australia
Primary sponsor type
Individual
Name
Dr. Barbara Zangerl
Address
Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country
Australia
Secondary sponsor category [1] 291109 0
University
Name [1] 291109 0
UNSW Australia
Address [1] 291109 0
Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country [1] 291109 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293882 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 293882 0
UNSW Australia
Sydney NSW 2052
Ethics committee country [1] 293882 0
Australia
Date submitted for ethics approval [1] 293882 0
24/11/2015
Approval date [1] 293882 0
18/12/2015
Ethics approval number [1] 293882 0
HC15838

Summary
Brief summary
Understanding diurnal IOP variations over a 6 week period may provide clinically useful information to guide management decisions in patients with confirmed glaucoma who are commencing treatment or patients at risk of developing glaucoma. We hypothesize that extended IOP self-monitoring will provide refined insight of the patient’s response to treatment and diurnal IOP data that should enhance classification of the patients according to glaucoma progression risk. Such results may significantly alter glaucoma management and improve outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61674 0
Dr Barbara Zangerl
Address 61674 0
The Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 61674 0
Australia
Phone 61674 0
+61 2 8118 0793
Fax 61674 0
Email 61674 0
[email protected]
Contact person for public queries
Name 61675 0
Barbara Zangerl
Address 61675 0
The Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 61675 0
Australia
Phone 61675 0
+61 2 8118 0793
Fax 61675 0
Email 61675 0
[email protected]
Contact person for scientific queries
Name 61676 0
Barbara Zangerl
Address 61676 0
The Centre for Eye Health
The University of New South Wales
Rupert Myers Building (south wing)
Barker St, Gate 14
Kensington NSW 2052
Country 61676 0
Australia
Phone 61676 0
+61 2 8118 0793
Fax 61676 0
Email 61676 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIDiurnal Intraocular Pressure Fluctuations with Self-tonometry in Glaucoma Patients and Suspects2018https://doi.org/10.1097/opx.0000000000001172
N.B. These documents automatically identified may not have been verified by the study sponsor.