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Confidential: for Review Only BMJ Confidential: For Review Only Defining a new threshold for ocular hypertension and estimating referral burden from the EPIC-Norfolk Eye Study: a cross-sectional study of the potential impact on referrals to the Hospital Eye Services Journal: BMJ Manuscript ID BMJ.2016.036789 Article Type: Research BMJ Journal: BMJ Date Submitted by the Author: 21-Dec-2016 Complete List of Authors: Chan, Michelle; UCL Institute of Ophthalmology , Division of Genetics & Epidemiology Broadway, David; Norfolk and Norwich University Hospital, Department of Ophthalmology Khawaja, Anthony; University of Cambridge, Department of Public Health & Primary Care Garway-Heath, David; NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology , Optometry Burr, Jennifer; Universityof St Andrews, School of Medicine Luben, Robert; University of Cambridge, Department of Public Health and Primary Care Hayat, Shabina; University of Cambridge, Department of Public Health & Primary Care Dalzell, Nichola; University of Cambridge, Department of Public Health & Primary Care Khaw, Kay-Tee; University of Cambridge, Clinical Medicine Foster, Paul; Moorfields Eye Hopsital NHS Foundation Trust, Intraocular pressure, Glaucoma, Ocular tonometry, Ocular hypertension, Keywords: England https://mc.manuscriptcentral.com/bmj Page 1 of 24 BMJ 1 2 3 Defining a new threshold for ocular hypertension and estimating referral burden from 4 the EPIC-Norfolk Eye Study: a cross-sectional study of the potential impact on 5 6 referrals to the Hospital Eye Services 7 8 Confidential: For Review Only 9 Michelle P Y Chan, David C Broadway, Anthony P Khawaja, David F Garway-Heath, 10 11 Jennifer M Burr, Robert Luben, Shabina Hayat, Nichola Dalzell, Kay-Tee Khaw, Paul J 12 Foster 13 14 15 Division of Genetics and Epidemiology, UCL Institute of Ophthalmology, 11-43 Bath Street, 16 London EC1V 9EL, UK. Michelle P Y Chan research fellow 17 18 19 Department of Ophthalmology, Norfolk and Norwich University Hospital NHS Foundation 20 Trust, Norwich NR4 7UY & University of East Anglia, Norwich, NR4 7TJ, UK. David C 21 Broadway professor 22 23 Department of Public Health & Primary Care, University of Cambridge, Cambridge CB1 24 25 8RN, UK. Anthony P Khawaja research fellow, Robert Luben head of biomedical informatics, 26 Shabina Hayat research co-ordinator, Nichola Dalzell study co-ordinator, Kay-Tee Khaw 27 professor 28 29 NIHR Biomedical Research Centre Moorfields Eye Hospital NHS Foundation Trust, 162 City 30 Road, London EC1V 2PD, UK and UCL Institute of Ophthalmology, 11-43 Bath Street, 31 32 London EC1V 9EL UK. Paul J Foster professor, David F Garway-Heath professor 33 34 School of Medicine, Medical & Biological Sciences, University of St Andrews, North Haugh, 35 St. Andrews KY16 9TF, UK. Jennifer M Burr reader 36 37 38 39 40 41 Correspondence to: 42 Prof Paul Foster 43 44 Email: [email protected] 45 46 Keywords (MeSH): 47 48 Intraocular pressure, Glaucoma, Ocular tonometry, Ocular hypertension, England 49 50 51 Word Count: 3382 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj1 BMJ Page 2 of 24 1 2 3 ABSTRACT 4 5 6 Objectives 7 To re-examine the basis for intraocular pressure (IOP) thresholds used to define ocular 8 Confidential: For Review Only 9 hypertension (OHT), and to determine the potential referral burden to the Hospital Eye 10 11 Service if the definition for OHT was altered. 12 13 14 Design 15 A community-based cross-sectional observational study: the European Prospective 16 17 Investigation of Cancer (EPIC)-Norfolk Eye Study. 18 19 20 Setting 21 The city of Norwich and the surrounding rural and urban areas. 22 23 24 Participants 25 26 7544 participants aged 48-92 years who did not have glaucoma or use ocular hypotensive 27 drops with IOP measurements using Ocular Response Analyzer non-contact tonometer. 28 29 30 Main outcome measures 31 32 IOP threshold defining OHT (mean IOP + two standard deviations (SD)) by age and sex, 33 was compared to the 97.5 th centile of IOP. Projected numbers of referable cases at different 34 35 IOP thresholds (highest from either eye) in England and Wales. 36 37 38 Results 39 40 The study population’s mean Goldmann-correlated IOP (IOPg) in the right eye was 41 16.2mmHg (95% CI 16.1-16.3mmHg, SD 3.7mmHg). The OHT threshold (mean+2SD) was 42 43 23.6mmHg; this value ranged between 22.8-24.6mmHg in men and 22.6-24.3mmHg in 44 women across the range of ages. For “standard” NCT measurements, t he mean+2SD 45 46 values were 21.5-21.6mmHg. Allowing for the skew in the data, the 97.5 centile is higher at 47 48 24.1-24.6mmHg for IOPg and 22.7-23.4mmHg for NCT measurements. 49 50 51 If a 24mmHg referral threshold were applied, the projected number of subjects eligible for 52 53 referral in England and Wales on the basis of raised IOP alone would be reduced by 69.4%; 54 if 22mmHg were adopted, the potential reduction would still be substantial at 33.0%. Raising 55 56 the IOP threshold from 21mmHg to 24mmHg could cause up to an extra 16% of 57 58 59 60 https://mc.manuscriptcentral.com/bmj2 Page 3 of 24 BMJ 1 2 3 undiagnosed glaucoma cases and extra 12% of undiagnosed glaucoma suspects to be 4 5 missed. No single IOP measure was a reliable case-finding tool. 6 7 8 Confidential:Conclusions For Review Only 9 A significant reduction in unnecessary referrals could be made, with a modest loss of case 10 11 finding performance, if IOP threshold for referral for OHT to the Hospital Eye Service were 12 increased above the current threshold of 21mmHg. Careful consideration should be given 13 14 when balancing the benefits and drawbacks of such a change. 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj3 BMJ Page 4 of 24 1 2 3 INTRODUCTION 4 5 6 Glaucoma is the leading cause of irreversible blindness in the world 1 and the second most 7 common cause of registered blindness in England and Wales. 2 It comprises a group of 8 Confidential: For Review Only 9 ocular diseases characterized by progressive damage of the optic nerve.3 Glaucoma and 10 11 suspect glaucoma combined account for the fifth largest share of NHS outpatient 12 attendances in England, after breast cancer, schizophrenia, prostate cancer and joint pain. 4 13 14 The most common type of glaucoma is primary open angle glaucoma (POAG). Elevated 15 intraocular pressure (IOP) is the major modifiable risk factor for POAG. 5 6 7 However, around 16 8 17 50% of glaucoma cases present with IOP within the statistically ‘normal’ range. The ‘normal’ 18 values originate from the 1966 MRC Rhondda Valley population survey.9 Among participants 19 20 with no evidence of glaucoma, the IOP two standard deviations above the population mean 21 was chosen to identify the top 2.5% of the population distribution. This varied according to 22 23 sex and eye laterality, ranging between 20.522.5mmHg. Since then, IOP >21mmHg has 24 become deeply entrenched as a threshold for ocular hypertension (OHT), and deemed 25 26 requiring medical assessment. OHT accounts for 30-45% of all referrals made to NHS 27 Hospital Eye Service in the UK.10 11 In 2010, the UK’s ophthalmic (Royal College of 28 29 Ophthalmologists - RCOphth) and optometric (College of Optometry - CoO) professional 30 bodies recommended that opticians should refer anyone with IOP >21 to the Hospital Eye 31 32 Service, even if it was the sole abnormality. 12 33 34 35 Goldmann applanation tonometry (GAT) used in the 1966 MRC survey is the hospital 36 37 standard technique for measurement of IOP. GAT is more accurate and precise than non- 38 contact tonometer (NCT) - the most widely used technique for IOP measurement in 39 13 14 40 community optometric practices, The RCOphth/CoO recommendations specified that, if 41 GAT was not available, an average of four readings NCT should be taken, but did not 42 43 consider the impact of greater measurement variability on the statistical “upper limit of 44 normal”. 45 46 47 For these reasons, there is a need to re-examine the IOP distribution in a UK population 48 49 examined with non-contact devices, to ensure that IOP referral thresholds are suited to 50 modern purposes. The aim of this study was to report the IOP distribution in a large UK 51 52 population, and to estimate the effect of different IOP referral thresholds on the referable 53 numbers to the NHS Hospital Eye Service. 54 55 56 METHODS 57 58 The European Prospective Investigation of Cancer (EPIC) study is a pan-European multi- 59 60 https://mc.manuscriptcentral.com/bmj4 Page 5 of 24 BMJ 1 2 3 cohort study, designed to investigate the lifestyle determinants of cancer risks. The EPIC- 4 Norfolk cohort was established in the city of Norwich and the surrounding rural and urban 5 6 areas, in the eastern English county of Norfolk, between 1993-1997. 15 A total of 30,445 men 7 and women aged 40-79 years were recruited at a baseline survey from the databases of 35 8 Confidential: For Review Only 9 general practices. The predominant ethnicity of the cohort was White, and included 10 11 individuals with a range of socioeconomic status and educational achievements.
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