Glaucoma, a chronic and progressive disease, is characterized by evidence of optic nerve deterioration, loss of retinal ganglion cell axons (RGCs) and progressive, irreversible loss of visual acuity, peripheral and central visual fields. Glaucoma is currently the second leading cause of severe visual impairment and blindness in the world and has a global prevalence of 3.54% 4. As of late 2019, the prevalence of glaucoma was 1.3 million in the United Kingdom (UK), representing just over 2% of UK residents 40 years of age or older
There are four types of glaucoma: open angle (OAG), the most common; angle closure; secondary, and childhood. Current pharmaceutical and surgical interventions for OAG and ocular hypertension (OHT), which may lead to OAG, aim to reduce intraocular pressure (IOP). Many patients have difficulty adhering to pharmaceutical treatment for IOP, which can lead to extensive vision loss and increased healthcare costs if left untreated.
To better understand what may be driving IOP treatment nonadherence, this study aims to assess demographic and clinical characteristics of patients diagnosed with OAG or OHT in the UK, as well as their most common treatment patterns, resource utilization, and potentially associated clinical outcomes in both primary and secondary care environments in the UK.
This study aims to assess demographic and clinical characteristics of patients in the UK diagnosed with OAG or OHT and to describe glaucoma disease management including treatment patterns, healthcare resource utilization, and associated clinical outcomes in both the primary and secondary care settings.
Early diagnosis and treatment of patients with glaucoma can improve health outcomes, including disease progression, over time.The purpose of this study is to estimate the burden of disease for patients diagnosed with glaucoma and to better understand its economic impact to the healthcare system in England and Wales. The findings from this study would improve patient care for patients diagnosed with glaucoma and/or ocular hypertension in England and Wales by directly informing clinical practices about best practices for optimal health outcomes, resource utilization, cost, and treatment options when specific modes of administration are not feasible.
Two cohorts will be built for the study during the time period of interest, January 1, 2014 –December 31, 2019. The first cohort will be built from the CPRD Aurum data linked to the HES datasets (Admitted patient care: January 2014 to December 2019. Data collected from Cohort 1 and Cohort 2 will include patient-level characteristics, glaucoma treatment data, visits to health care provider(s), and relevant procedures. Patient variables from Cohort 1 will be used to match to Cohort 2 using probabilistic matching methods. Data from both cohorts will remain de-identified and no direct patient-level match between Cohort 1 and Cohort 2 will occur. The patient cohorts will be stratified at index by exposure to prescription eyedrop treatment, eyedrop tolerance, and eyedrop installation ability. Eyedrop prescriptions categories for the study are prostaglandin analogues, beta blockers, alpha agonists, carbonic anhydrase inhibitors, and rho kinase inhibitors. The clinical outcomes of interest are intraocular pressure control, disease severity (visual field progression), and potential adverse events. Chi square and multivariate analyses will be done to identify statistically significant differences and/ or potential associations of treatments with outcomes or time to change in intraocular pressure control, visual field progression, and specific adverse events found to be associated with treatment.
The outcomes to be measured are 1) intraocular pressure control; 2) disease severity as measured by: visual field progression, intraocular pressure (IOP); cup-to-disc (CD) ratio; reduction in retinal nerve fibre layer (RNFL) and ganglion cell layer (GCL) thickness; and 3) adverse events that may be related to eye drop treatment, including: conjunctival allergies, conjunctival injection; corneal epithelium disorders; blepharitis; ocular pemphigoid; corneal sensitivity; corneal epithelium disorders; relaxation bronchial; urinary; and vascular smooth muscles; bradycardia; blood pressure decrease; irregular pulse; increase in asthma attacks; chronic obstructive pulmonary disease; headaches; depression; anxiety; confusion; dysarthria; hallucinations; somnolence tendencies; and lethargy.
Please see the list of variables here and the codes for these variables in the Appendices:
• Visual Field
• Intraocular Pressure Control
• Disease Severity (Visual Field Progression)
• IOP
• CD Ratio
• Reduction in RNFL and GCL thickness
• Conjunctival allergies
• Conjunctival injection
• Blepharitis
• Ocular pemphigoid
• Corneal sensitivity
• Corneal epithelium disorders
• Relaxation bronchial, urinary, and vascular smooth muscles
• Bradycardia
• Blood pressure decrease
• Irregular pulse
• Increase in asthma attacks
• Chronic obstructive pulmonary disease
• Headaches
• Depression
• Anxiety
• Confusion
• Dysarthria
• Hallucinations
• Somnolence tendencies
• Lethargy
Camelia Graham - Chief Investigator - Parexel International LLC (USA)
Edon Morina - Corresponding Applicant - Parexel Denmark A/S
Ron Stewart - Collaborator - Parexel International LLC (USA)
Shea O'Connell - Collaborator - Parexel International (UK) Ltd
Bing Li - Collaborator - Parexel Sweden AB
Brian Mitchell - Collaborator - Parexel International LLC (USA)
Jay Were - Collaborator - HERON Evidence Development Ltd (UK)
Ron Stewart - Collaborator - Parexel International LLC (USA)
Shea O'Connell - Collaborator - Parexel International (UK) Ltd
Virginie Nael - Collaborator - PAREXEL International Corporation
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data