None listed
Conditions
Brief summary
The aim of the study is to identify risk factors for glaucoma progression (worsening of glaucoma) independent of the eye pressure, but specific to open angle glaucoma, which may include a combination of genetic, metabolic and lifestyle factors, and provide a deeper understanding on how optic nerve damage occurs in open angle glaucoma. The knowledge gained will help improve early detection, guide prevention strategies and support development of new treatments that target more than just eye pressure. This study will follow patients with glaucoma, optic neuropathy and healthy controls (no eye disease) for five years. All study participants will receive care consistent with standard clinical practice. Open angle glaucoma and optic neuropathy participants will undergo routine clinical management, while no experimental interventions will be applied during this observational study.
Interventions
Current treatments for primary open-angle glaucoma aim to reduce intraocular pressure (IOP),however interventions only slow disease progression and cannot reverse vision loss, are often less effective especially in cases of delayed diagnosis or poor treatment adherence, and often fail to halt disease progression, particularly when IOP is already in the normal range.
OMEGA is a prospective observational study where no interventions will be applied. Patients enrolled into OMEGA will be followed a
Current treatments for primary open-angle glaucoma aim to reduce intraocular pressure (IOP),however interventions only slow disease progression and cannot reverse vision loss, are often less effective especially in cases of delayed diagnosis or poor treatment adherence, and often fail to halt disease progression, particularly when IOP is already in the normal range. OMEGA is a prospective observational study where no interventions will be applied. Patients enrolled into OMEGA will be followed across a five-year period, and three cohorts will be included: 1) Open-angle glaucoma cohort: Patients followed longitudinally under usual care (at least every six months) 2) Optic neuropathy comparator cohort: Individuals with mitochondrial optic neuropathies, toxic optic neuropathies or optic disc drusen followed longitudinally under usual care (every twelve months) 3) Control comparator cohort: Age-matched individuals without glaucoma or optic neuropathy, followed at 2.5 years and 5 years. At these study visits, routine clinical ophthalmology data will be collected. Additionally, at baseline, study midpoint (between 2.5 and 3 years) and study endpoint (5 years), online questionnaires (IPAQ-Long, PSQI, STOP-Bang, GAL-9 and ASA-24) will be administered. The first four questionnaires are anticipated to take no longer than 15 minutes to complete in total. The ASA-24 will be completed three times across three consecutive days, with each attempt anticipated to take no longer than 40 minutes to complete.
Sponsors
University of Sydney
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
General (across all cohorts): - Best corrected visual acuity equal to or better than 6/12 in the better-seeing eye - Open angle on gonioscopy, defined as Shaffer grade of 3 or more in at least two quadrants and equal to 2 in the remaining quadrants without evidence of angle closure or peripheral anterior synechiae - Refractive error: spherical equivalent between -6.0 D and +6.0D (inclusive) and cylinder correction between -3.0 D and +3.0D (inclusive) - Willingness to provide informed consent and willingness to participate and comply with the study requirements, including timing and/or nature of required assessments Open-angle glaucoma cohort: - Diagnosis of glaucomatous optic neuropathy, confirmed by the presence of all three of the following: o Clinical examination findings consistent with glaucomatous optic neuropathy o Evidence of glaucomatous structural damage on optical coherence tomography o Visual field showing glaucomatous visual field loss - Maximum IOP less than 30mmHg at any time point on record, as measured using Goldman applanation tonometry - Visual field mean deviation between -2dB and-18dB in the better-seeing eye Optic neuropathy cohort: - Diagnosis of optic disc drusen, as evidenced by clinical examination (including bio-microscopy), B-scan ultrasound, optical coherence tomography, and visual field loss with mean deviation between -2dB and -18dB in the better-seeing eye OR - Diagnosis of any of Leber Hereditary Optic Neuropathy, Autosomal Dominant Optic Atrophy, another mitochrondrial optic neuropathy or toxic optic neuropathy Control cohort: - IOP between 10-22mmHg, as measured using Goldman applanation tonometry at the baseline visit - A healthy optic disc and retinal nerve fibre layer appearance, as assessed during clinical examination
Exclusion criteria
General (across all cohorts): - Refractive error: spherical equivalent greater than ±6.0 D or cylinder correction greater than ±3.0 D - Presence of any conditions that may cause non-glaucomatous visual field defect (for example: severe ptosis, cerebrovascular accident, prior pan-retinal photocoagulation, prior retinal detachments, prior venous or arterial occlusions and other retinal or central nervous system diseases) - Concurrent diagnosis of other optic neuropathies, demyelinating diseases (e.g., multiple sclerosis) or previous optic neuritis - Low likelihood of being available for ocular examination and reassessment according to the study schedule across a 5-year period - Lacking capacity to provide informed consent as determined by the treating clinician - Presence of any medical condition which in the investigator’s opinion would preclude the patient from providing reliable and valid data (e.g., cognitive impairment) Open-angle glaucoma cohort: - Diagnosis of any secondary open angle glaucoma, including but not limited to pseudo-exfoliation glaucoma, pigmentary dispersion glaucoma, steroid-induced glaucoma, other identifiable secondary causes of open angle glaucoma - Diagnosis of primary angle closure suspect status - Diagnosis of primary angle closure glaucoma - Historically unreliable visual field performer (>33% fixation losses or >15% false positives) Optic neuropathy cohort: - Diagnosis of any type of glaucoma - Family history of glaucoma in a first-degree relative (parent, sibling or child) - Classification as a glaucoma suspect (e.g., suspicious optic nerve findings or borderline visual field defects without confirmed glaucoma) - Current or past use of intraocular pressure-lowering medication or intervention - IOP > 22 mmHg (current or at any time point on record) Control cohort: Optic neuropathy cohort: - Diagnosis of any type of glaucoma - Family history of glaucoma in a first-degree relative (parent, sibling or child) - Classification as a glaucoma suspect (e.g., suspicious optic nerve findings or borderline visual field defects without confirmed glaucoma) - A history or evidence of ocular hypertension, defined as: o IOP >22mmHg on at least two separate occasions AND o Normal optic nerve head appearance and visual field results
Outcome results
None listed