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)
• CD Ratio
• Reduction in RNFL and GCL thickness
• Conjunctival allergies
• Conjunctival injection
• Ocular pemphigoid
• Corneal sensitivity
• Corneal epithelium disorders
• Relaxation bronchial, urinary, and vascular smooth muscles
• Blood pressure decrease
• Irregular pulse
• Increase in asthma attacks
• Chronic obstructive pulmonary disease
• Somnolence tendencies
Camelia Graham - Chief Investigator - Parexel International LLC
Edon Morina - Corresponding Applicant - Parexel Denmark A/S
Ron Stewart - Collaborator - Parexel International LLC
Shea O'Connell - Collaborator - HERON Evidence Development Ltd