None listed
Conditions
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.
Interventions
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 numbe
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.
Sponsors
Dr. Barbara Zangerl
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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)
Outcome results
None listed