None listed
Conditions
Brief summary
This 3 year study will observe longitudinal changes to vision in glaucoma using two different visual field testing (perimetry) methods. Glaucoma is a disease of the optic nerve in which peripheral vision is lost. Visual damage in glaucoma is typically measured using a visual field test, which measures the ability to see small white-light targets at various locations spread across the visual field. Current visual field tests use the same test pattern for all people with glaucoma. The primary aim of this study is to observe whether alternate test grids enable earlier detection of progressive damage to the visual field. Clinicians use visual field test information in combination with information from imaging of the eye to make decisions regarding whether people need more treatment. The secondary aim of this study is to combine the information from the visual field tests with information from retinal imaging to improve understanding of how glaucoma progresses.
Interventions
This is a single centre, interventional, longitudinal study comparing several methods of evaluating the status of the visual field in people with glaucoma. Visual field assessments of peripheral vision will be compared to several forms of ophthalmic imaging. Current clinical visual field testing procedures for glaucoma use the same regularly spaced test grid for all people. The intervention to be tested is a visual field testing grid that is customised for the specific individual being tested (for example, to avoid retesting locations in visual space that are known to be blind, and to instead test areas along the border of these regions). This study will compare whether customised testing grids are better able to observe progressing damage to the visual field than the current approach of using the same test grid for all (known as the 24-2 testing grid). The study will also relate measured visual field status and progression rates to structural biomarkers of glaucoma measured with ophthalmic imaging. Specifically, the study will measure visual fields using a 24-2 test pattern and using the Australian Reduced Range Extended Spatial Test (ARREST) (Turpin, Morgan et al. 2018, Muthusamy, Turpin et al. 2020), which customises the stimulus placement. Each of these tests take approximately 5-8 minutes to complete per eye and will be conducted on the Compass perimeter hardware (CentreVue, SpA, Italy). The Compass perimeter is a commercially available visual field testing machine. Participants look into the machine, and press a button every time they see a small white light appear anywhere in their visual field. In addition to the visual field tests, the study will collect: a) structural Optical Coherence Tomography (OCT) image of the optic nerve, retinal nerve fibre layer, and macular regions using the Spectralis OCT (Heidelberg Engineering, GmBH, Germany) : b) OCT angiography measures of the optic nerve and macular regions to non-invasively estimate blood flow (using the Spectralis OCT; c) retinal photography using the Compass Perimeter; d) two additional measures of visual function: 1) macular ON-OFF pathway function (measured using a customised test on an iPad; and 2) an estimate of individual psychometric function slope for Size III perimetric targets in normal regions of visual field (measured using custom software on the Compass Perimeter hardware). All imaging methods (OCT, OCT Angiography and retinal photograph) are well accepted clinical assessments that each take no more than 2 minute to collect (including set-up time, imaging acquisition is a few seconds). Participants sit in a darkened room and view a fixation target while the images are acquired. The ON-OFF pathway test involves looking a a chequered pattern on an iPad and pressing a button on the tablet to indicate whether 1, 2 or 3 dark or light targets are seen embedded in the chequered pattern. This test takes approximately 5 minutes. In total, the study visit will take approximately 90 minutes. The study will observe the natural history of glaucomatous progression using these different methodologies. Measurements will be taken (visual fields using the standard and customised test patterns, and ophthalmic imaging) every 4 months for 3 years. ON-OFF pathway function and psychometric function slope will only be measured at the first and last visit. Tests will be conducted by AHPRA registered optometrists or trained ophthalmic technicians.
Sponsors
Study design
Eligibility
Inclusion criteria
• established diagnosis of primary open-angle or pseudoexfoliative glaucoma or pigment dispersion open angle glaucoma (OAG), (as defined by the treating ophthalmologist in accordance with internationally accepted clinical criteria). • prior history of repeatable evidence of visual field defects on the 24-2 test pattern consistent with the diagnosis of glaucomatous optic neuropathy, with at least 2 locations in the visual field with visual field sensitivity < 17dB in at least ONE eye (locations do not need to be contiguous). • aged between 18 – 80 years. • participants whom in the opinion of the investigator are considered likely to attend for 3 visits per annum for the next 3 years , in addition to an additional baseline study visit • one of more clinical features that increase the likelihood of visual field progression including: visual field progression over the last 2 years, disc haemorrhages, age greater than 60 years, intra-ocular pressure (IOP) above target pressure, family history of glaucoma-related vision loss, thin central cornea (<510um). • best corrected visual acuity better than 6/12 at enrolment.
Exclusion criteria
• Patients with significant ocular comorbidities (other than glaucoma) • Patients that have had previous glaucoma surgery and have IOP less than 12 mm Hg • Patients with advanced glaucoma with MD greater than -20 dB • Patients with visually significant cataracts in which surgery is planned or anticipated within the next 6 months. • Patients with primary angle closure glaucoma or narrow angles in which laser iridotomy is planned or anticipated within the next 3 months. • Patients with a history of LASIK surgery • Patients with myopia greater than -6.0 diopters. • Patients with hyperopia greater than +6.0 diopters. • People with poorly controlled diabetes, type I diabetes, diabetic retinopathy, or other significant systemic condition that is likely to influence visual function over the course of the study. • Any other medical condition which would prohibit them from making all study visits within the 36 months • In the investigator's opinion, any patient that cannot satisfactorily complete all of the structural and functional testing included in the protocol • Patients unable to perform reliable VF testing (reliable testing defined as: false positive rate of 20% or less) at the time of study entry