PREFERRED PRACTICE PATTERN®
`
` :
`
`' L'
`
`Primary
`Open-Angle
`Glaucoma
`
`AMERICAN ACADEMY”
`or OPHTHALMOLOGY
`The Eye M.D. Association
`
`© 2016 by the American Academy of Ophthalmology
`Published by Elsevier Inc.
`
`P41
`
`http://dx.doi.org/l0.1016/j.0phfl1a.2015.10.053
`ISSN 0161-6420/16
`
`Argentum Pharm. LLC V. Alcon Research, Ltd.
`Case IPR2017-01053
`
`ALCON 2129
`
`

`

`(cid:3)
`
`Secretary for Quality of Care
`Stephen D. McLeod, MD
`
`Academy Staff
`Nicholas P. Emptage, MAE
`Doris Mizuiri
`Laurie Bagley, MLS
`Flora C. Lum, MD
`
`Medical Editor:
`Design:
`
`Susan Garratt
`Socorro Soberano
`
`Approved by:
`
`Board of Trustees
`September 18, 2015
`
`Copyright © 2015 American Academy of Ophthalmology®
`All rights reserved
`
`AMERICAN ACADEMY OF OPHTHALMOLOGY and PREFERRED PRACTICE PATTERN are
`registered trademarks of the American Academy of Ophthalmology. All other trademarks are the property of
`their respective owners.
`
`Preferred Practice Pattern® guidelines are developed by the Academy’s H. Dunbar Hoskins Jr., MD Center
`for Quality Eye Care without any external financial support. Authors and reviewers of the guidelines are
`volunteers and do not receive any financial compensation for their contributions to the documents. The
`guidelines are externally reviewed by experts and stakeholders before publication.
`
`P42
`
`

`

`Primary Open-Angle Glaucoma PPP
`
`(cid:3)
`
`GLAUCOMA PREFERRED PRACTICE
`PATTERN® DEVELOPMENT PROCESS
`AND PARTICIPANTS
`The Glaucoma Preferred Practice Pattern® Panel members wrote the Primary Open-Angle
`Glaucoma Preferred Practice Pattern® guidelines (“PPP”). The PPP Panel members discussed
`and reviewed successive drafts of the document, meeting in person twice and conducting other
`review by e-mail discussion, to develop a consensus over the final version of the document.
`
`Glaucoma Preferred Practice Pattern Panel 2014–2015
`Bruce E. Prum, Jr., MD, Co-chair
`Lisa F. Rosenberg, MD
`Steven J. Gedde, MD
`Steven L. Mansberger, MD, MPH, Methodologist
`Joshua D. Stein, MD, MS, American Glaucoma Society Representative
`Sayoko E. Moroi, MD, PhD
`Leon W. Herndon, Jr., MD
`Michele C. Lim, MD
`Ruth D. Williams, MD, Co-chair
`
`The Preferred Practice Patterns Committee members reviewed and discussed the document
`during a meeting in April 2015. The document was edited in response to the discussion and
`comments.
`
`Preferred Practice Patterns Committee 2015
`Robert S. Feder, MD, Chair
`Timothy W. Olsen, MD
`Randall J. Olson, MD
`Bruce E. Prum, Jr., MD
`C. Gail Summers, MD
`Ruth D. Williams, MD
`David C. Musch, PhD, MPH, Methodologist
`
`The Primary Open-Angle Glaucoma PPP was then sent for review to additional internal and
`external groups and individuals in July 2015. All those who returned comments were required to
`provide disclosure of relevant relationships with industry to have their comments considered
`(indicated with an asterisk below). Members of the PPP Panel reviewed and discussed these
`comments and determined revisions to the document.
`
`Academy Reviewers
`Board of Trustees and Committee of Secretaries*
`Council*
`General Counsel*
`Ophthalmic Technology Assessment Committee
`Glaucoma Panel*
`Basic and Clinical Science Course Section 10
`Subcommittee
`Practicing Ophthalmologists Advisory Committee
`for Education*
`
`Invited Reviewers
`American Academy of Family Physicians
`American College of Physicians*
`American College of Surgeons
`American Glaucoma Society*
`American Ophthalmological Society*
`American Society of Cataract & Refractive
`Surgery
`
`Association of University Professors of
`Ophthalmology
`Canadian Ophthalmological Society
`Consumer Reports Health Choices
`European Glaucoma Society*
`European Society of Cataract and Refractive
`Surgeons
`Glaucoma Research Foundation*
`Greek Glaucoma Society*
`International Society of Refractive Surgery
`National Eye Institute*
`National Medical Association
`National Partnership of Women and Families
`Outpatient Ophthalmic Surgery Society
`Women in Ophthalmology*
`James D. Brandt, MD
`Donald L. Budenz, MD, MPH
`Lawrence M. Hurvitz, MD*
`Paul P. Lee, MD, JD
`
`P43
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`

`

`Primary Open-Angle Glaucoma PPP
`
`FINANCIAL DISCLOSURES
`
`(cid:3)
`
`In compliance with the Council of Medical Specialty Societies’ Code for Interactions with Companies
`(available at www.cmss.org/codeforinteractions.aspx), relevant relationships with industry are listed. The
`Academy has Relationship with Industry Procedures to comply with the Code (available at www.aao.org/about-
`preferred-practice-patterns). A majority (56%) of the members of the Glaucoma Preferred Practice Pattern Panel
`2014–2015 had no related financial relationship to disclose.
`
`Glaucoma Preferred Practice Pattern Panel 2014–2015
`Steven J. Gedde, MD: Alcon Laboratories, Inc., Allergan – Consultant/Advisor
`Leon W. Herndon, Jr., MD: Alcon Laboratories, Inc. – Consultant/Advisor, Lecture fees; Glaukos
`Corporation – Lecture fees
`Michele C. Lim, MD: No financial relationships to disclose
`Steven L. Mansberger, MD, MPH: Alcon Laboratories, Inc., Allergan, Glaukos Corporation –
`Consultant/Advisor
`Sayoko E. Moroi, MD, PhD: No financial relationships to disclose
`Bruce E. Prum, Jr., MD: No financial relationships to disclose
`Lisa F. Rosenberg, MD: No financial relationships to disclose
`Joshua D. Stein, MD, MS: No financial relationships to disclose
`Ruth D. Williams, MD: Allergan – Consultant/Advisor
`
`Preferred Practice Patterns Committee 2015
`Robert S. Feder, MD: No financial relationships to disclose
`David C. Musch, PhD, MPH: Glaukos Corporation, InnFocus, LLC, Ivantis, Inc. – Consultant/Advisor
`(Data & Safety Monitoring Board member for clinical trials)
`Timothy W. Olsen, MD: No financial relationships to disclose
`Randall J. Olson, MD: No financial relationships to disclose
`Bruce E. Prum, Jr., MD: No financial relationships to disclose
`C. Gail Summers, MD: No financial relationships to disclose
`Ruth D. Williams, MD: Allergan – Consultant/Advisor
`
`Secretary for Quality of Care
`Stephen D. McLeod, MD: No financial relationships to disclose
`
`Academy Staff
`Laurie Bagley, MLS: No financial relationships to disclose
`Nicholas P. Emptage, MAE: No financial relationships to disclose
`Susan Garratt: No financial relationships to disclose
`Flora C. Lum, MD: No financial relationships to disclose
`Doris Mizuiri: No financial relationships to disclose
`
`The disclosures of relevant relationships to industry of other reviewers of the document from January
`to August 2015 are available online at www.aao.org/ppp.
`
`P44
`
`

`

`Primary Open-Angle Glaucoma PPP
`
`TABLE OF CONTENTS
`
`OBJECTIVES OF PREFERRED PRACTICE PATTERN GUIDELINES .......................................... P46
`METHODS AND KEY TO RATINGS ................................................................................................ P47
`HIGHLIGHTED FINDINGS AND RECOMMENDATIONS FOR CARE ............................................ P48
`INTRODUCTION ............................................................................................................................... P49
`Disease Definition .............................................................................................................................. P49
`Clinical Findings Characteristic of Primary Open-Angle Glaucoma .................................................. P49
`Patient Population.............................................................................................................................. P50
`Clinical Objectives.............................................................................................................................. P50
`BACKGROUND................................................................................................................................. P50
`Prevalence ......................................................................................................................................... P50
`Risk Factors ....................................................................................................................................... P52
`Intraocular Pressure............................................................................................................................... P52
`Age ............................................................................................................................................. P54
`Family History............................................................................................................................. P54
`Race or Ethnicity......................................................................................................................... P54
`Central Corneal Thickness ......................................................................................................... P54
`Low Ocular Perfusion Pressure.................................................................................................. P55
`Type 2 Diabetes Mellitus ............................................................................................................ P55
`Myopia ........................................................................................................................................ P56
`Other Factors.............................................................................................................................. P56
`POPULATION SCREENING FOR GLAUCOMA.............................................................................. P57
`CARE PROCESS .............................................................................................................................. P58
`Patient Outcome Criteria.................................................................................................................... P58
`Diagnosis ........................................................................................................................................... P58
`History......................................................................................................................................... P58
`Evaluation of Visual Function ..................................................................................................... P58
`Physical Examination ................................................................................................................. P58
`Diagnostic Testing ...................................................................................................................... P60
`Differential Diagnosis.................................................................................................................. P62
`Management ...................................................................................................................................... P63
`Goals .......................................................................................................................................... P63
`Target Intraocular Pressure for Patients with POAG.................................................................. P63
`Choice of Therapy ...................................................................................................................... P64
`Follow-up Evaluation .................................................................................................................. P75
`Risk Factors for Progression ...................................................................................................... P77
`Adjustment of Therapy ............................................................................................................... P77
`Provider and Setting .......................................................................................................................... P78
`Counseling and Referral .................................................................................................................... P78
`Socioeconomic Considerations ......................................................................................................... P79
`APPENDIX 1. QUALITY OF OPHTHALMIC CARE CORE CRITERIA............................................ P81
`APPENDIX 2. INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES AND
`RELATED HEALTH PROBLEMS (ICD) CODES ..................................................................... P83
`APPENDIX 3. LITERATURE SEARCHES FOR THIS PPP ............................................................. P84
`SUGGESTED REFERENCE TEXTS ................................................................................................ P87
`RELATED ACADEMY MATERIALS................................................................................................. P87
`REFERENCES .................................................................................................................................. P88
`
`P45
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`Primary Open-Angle Glaucoma PPP
`
`OBJECTIVES OF PREFERRED
`PRACTICE PATTERN® GUIDELINES
`
`(cid:3)
`
`As a service to its members and the public, the American Academy of Ophthalmology has developed a series
`of Preferred Practice Pattern® guidelines that identify characteristics and components of quality eye care.
`Appendix 1 describes the core criteria of quality eye care.
`
`The Preferred Practice Pattern® guidelines are based on the best available scientific data as interpreted by
`panels of knowledgeable health professionals. In some instances, such as when results of carefully conducted
`clinical trials are available, the data are particularly persuasive and provide clear guidance. In other instances,
`the panels have to rely on their collective judgment and evaluation of available evidence.
`
`These documents provide guidance for the pattern of practice, not for the care of a particular individual.
`While they should generally meet the needs of most patients, they cannot possibly best meet the needs of all
`patients. Adherence to these PPPs will not ensure a successful outcome in every situation. These practice
`patterns should not be deemed inclusive of all proper methods of care or exclusive of other methods of care
`reasonably directed at obtaining the best results. It may be necessary to approach different patients’ needs in
`different ways. The physician must make the ultimate judgment about the propriety of the care of a particular
`patient in light of all of the circumstances presented by that patient. The American Academy of Ophthalmology
`is available to assist members in resolving ethical dilemmas that arise in the course of ophthalmic practice.
`
`Preferred Practice Pattern® guidelines are not medical standards to be adhered to in all individual
`situations. The Academy specifically disclaims any and all liability for injury or other damages of any kind,
`from negligence or otherwise, for any and all claims that may arise out of the use of any recommendations or
`other information contained herein.
`
`References to certain drugs, instruments, and other products are made for illustrative purposes only and are not
`intended to constitute an endorsement of such. Such material may include information on applications that are
`not considered community standard, that reflect indications not included in approved U.S. Food and Drug
`Administration (FDA) labeling, or that are approved for use only in restricted research settings. The FDA has
`stated that it is the responsibility of the physician to determine the FDA status of each drug or device he or she
`wishes to use, and to use them with appropriate patient consent in compliance with applicable law.
`
`Innovation in medicine is essential to ensure the future health of the American public, and the Academy
`encourages the development of new diagnostic and therapeutic methods that will improve eye care. It is
`essential to recognize that true medical excellence is achieved only when the patients’ needs are the foremost
`consideration.
`
`All Preferred Practice Pattern® guidelines are reviewed by their parent panel annually or earlier if
`developments warrant and updated accordingly. To ensure that all PPPs are current, each is valid for 5 years
`from the “approved by” date unless superseded by a revision. Preferred Practice Pattern guidelines are funded
`by the Academy without commercial support. Authors and reviewers of PPPs are volunteers and do not receive
`any financial compensation for their contributions to the documents. The PPPs are externally reviewed by
`experts and stakeholders, including consumer representatives, before publication. The PPPs are developed in
`compliance with the Council of Medical Specialty Societies’ Code for Interactions with Companies. The
`Academy has Relationship with Industry Procedures (available at www.aao.org/about-preferred-practice-
`patterns) to comply with the Code.
`
`Appendix 2 contains the International Statistical Classification of Diseases and Related Health Problems (ICD)
`codes for the disease entities that this PPP covers. The intended users of the Primary Open-Angle Glaucoma
`PPP are ophthalmologists.
`
`P46
`
`

`

`Primary Open-Angle Glaucoma PPP
`
`METHODS AND KEY TO RATINGS
`
`(cid:3)
`
`Preferred Practice Pattern® guidelines should be clinically relevant and specific enough to provide useful
`information to practitioners. Where evidence exists to support a recommendation for care, the
`recommendation should be given an explicit rating that shows the strength of evidence. To accomplish these
`aims, methods from the Scottish Intercollegiate Guideline Network1 (SIGN) and the Grading of
`Recommendations Assessment, Development and Evaluation2 (GRADE) group are used. GRADE is a
`systematic approach to grading the strength of the total body of evidence that is available to support
`recommendations on a specific clinical management issue. Organizations that have adopted GRADE include
`SIGN, the World Health Organization, the Agency for Healthcare Research and Policy, and the American
`College of Physicians.3
`(cid:139) All studies used to form a recommendation for care are graded for strength of evidence individually, and
`that grade is listed with the study citation.
`(cid:139) To rate individual studies, a scale based on SIGN1 is used. The definitions and levels of evidence to rate
`individual studies are as follows:
`
`I++
`
`I+
`I-
`II++
`
`II+
`
`II-
`
`III
`
`High-quality meta-analyses, systematic reviews of randomized controlled trials (RCTs), or
`RCTs with a very low risk of bias
`
`Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
`Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias
`High-quality systematic reviews of case-control or cohort studies
`High-quality case-control or cohort studies with a very low risk of confounding or bias and a
`high probability that the relationship is causal
`Well-conducted case-control or cohort studies with a low risk of confounding or bias and a
`moderate probability that the relationship is causal
`Case-control or cohort studies with a high risk of confounding or bias and a significant risk that
`the relationship is not causal
`Nonanalytic studies (e.g., case reports, case series)
`
`(cid:139) Recommendations for care are formed based on the body of the evidence. The body of evidence quality
`ratings are defined by GRADE2 as follows:
`
`Good quality
`
`Moderate quality
`
`Insufficient quality
`
`Further research is very unlikely to change our confidence in the estimate of
`effect
`Further research is likely to have an important impact on our confidence in the
`estimate of effect and may change the estimate
`Further research is very likely to have an important impact on our confidence in
`the estimate of effect and is likely to change the estimate
`Any estimate of effect is very uncertain
`
`(cid:139) Key recommendations for care are defined by GRADE2 as follows:
`
`Strong
`recommendation
`Discretionary
`recommendation
`
`Used when the desirable effects of an intervention clearly outweigh the
`undesirable effects or clearly do not
`Used when the trade-offs are less certain—either because of low-quality evidence
`or because evidence suggests that desirable and undesirable effects are closely
`balanced
`
`(cid:139) The Highlighted Findings and Recommendations for Care section lists points determined by the PPP
`Panel to be of particular importance to vision and quality of life outcomes.
`(cid:139) All recommendations for care in this PPP were rated using the system described above. Ratings are
`embedded throughout the PPP main text in italics.
`(cid:139) Literature searches to update the PPP were undertaken in June 2014 in the PubMed and Cochrane
`databases. Complete details of the literature searches are available in Appendix 3.
`
`P47
`
`

`

`Primary Open-Angle Glaucoma PPP
`
`HIGHLIGHTED FINDINGS AND
`RECOMMENDATIONS FOR CARE
`
`Established and important risk factors for primary open-angle glaucoma (POAG) include age, race/ethnicity,
`level of intraocular pressure (IOP), family history of glaucoma, low ocular perfusion pressure, type 2
`diabetes mellitus, myopia, and thin central cornea.
`
`Primary open-angle glaucoma with consistently normal IOP is common, especially in certain populations.
`Lowering pressure in these patients can be beneficial.
`
`Characteristic clinical features of POAG include an open angle on gonioscopy, and glaucomatous optic nerve
`head (ONH) and retinal nerve fiber layer (RNFL) changes that usually are associated with typical
`glaucomatous visual field defects.
`
`Computer-based imaging and stereoscopic photography provide different and complementary information
`about optic nerve status and are useful adjuncts to a good clinical examination.
`
`Adjusting computerized visual field programs (24 degrees, 30 degrees, 10 degrees) and varying stimulus size
`for patients with advanced glaucoma aid in detecting and monitoring progressive visual field loss.
`
`Clinical trials have shown that lowering IOP reduces the risk of developing POAG and slows the progression
`of POAG, including normal-tension OAG.
`
`Effective medical, laser, and incisional surgical approaches exist for lowering IOP.
`
`A reasonable initial treatment in a POAG patient is to reduce IOP 20%–30% below baseline and to adjust up
`or down as indicated by disease course and severity.
`
`P48
`
`

`

`INTRODUCTION
`
`Primary Open-Angle Glaucoma PPP
`
`DISEASE DEFINITION
`Primary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy in adults in which
`there is a characteristic acquired atrophy of the optic nerve and loss of retinal ganglion cells and their
`axons. This condition is associated with an open anterior chamber angle by gonioscopy.
`
`CLINICAL FINDINGS CHARACTERISTIC OF PRIMARY OPEN-ANGLE GLAUCOMA
`Primary open-angle glaucoma is a chronic ocular disease process that is progressive, generally
`bilateral, but often asymmetric.4 It is associated with the following characteristics.
`(cid:139) Evidence of optic nerve damage from either, or both, of the following:
`(cid:140) Optic disc or retinal nerve fiber layer (RNFL) structural abnormalities
`(cid:131) Diffuse or focal narrowing, or notching, of the optic disc rim, especially at the inferior or
`superior poles, which forms the basis for the ISNT rule5 (see subsection on optic nerve head
`and retinal nerve fiber layer clinical examination in Physical Examination section)
`(cid:131) Progressive narrowing of the neuroretinal rim with an associated increase in cupping of the
`optic disc
`(cid:131) Diffuse or localized abnormalities of the parapapillary RNFL, especially at the inferior or
`superior poles
`(cid:131) Disc rim, parapapillary RNFL, or lamina cribrosa hemorrhages
`(cid:131) Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
`(cid:131) Large extent of parapapillary atrophy
`(cid:140) Reliable and reproducible visual field abnormality considered a valid representation of the
`subject’s functional status
`(cid:131) Visual field damage consistent with RNFL damage (e.g., nasal step, arcuate field defect, or
`paracentral depression in clusters of test sites)6
`(cid:131) Visual field loss across the horizontal midline in one hemifield that exceeds loss in the
`opposite hemifield (in early/moderate cases)
`(cid:131) Absence of other known explanations (e.g., optic disc drusen, optic nerve pit)
`(cid:139) Adult onset
`(cid:139) Open anterior chamber angles
`(cid:139) Absence of other known explanations (i.e., secondary glaucoma) for progressive glaucomatous optic
`nerve change (e.g., pigment dispersion, pseudoexfoliation [exfoliation syndrome], uveitis, trauma, and
`corticosteroid use)
`
`Primary open-angle glaucoma represents a spectrum of disease in adults in which the susceptibility of
`the optic nerve to damage varies among patients. Although many patients with POAG present with
`elevated intraocular pressure (IOP), nearly 40% of those with otherwise characteristic POAG may not
`have elevated IOP measurements.7 The vast majority of patients with POAG have disc changes or disc
`and visual field changes,8 but there are rare cases where there may be early visual field changes before
`there are detectable changes to the optic nerve.
`
`P49
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`

`

`Primary Open-Angle Glaucoma PPP:
`Background
`
`The severity of glaucoma damage can be estimated according to the following categories:
`(cid:139) Mild: definite optic disc or RNFL abnormalities consistent with glaucoma as detailed above and a
`normal visual field as tested with standard automated perimetry (SAP)
`(cid:139) Moderate: definite optic disc or RNFL abnormalities consistent with glaucoma as detailed above, and
`visual field abnormalities in one hemifield that are not within 5 degrees of fixation as tested with SAP
`(cid:139) Severe: definite optic disc or RNFL abnormalities consistent with glaucoma as detailed above, and
`visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one
`hemifield as tested with SAP
`(cid:139) Indeterminate: definite optic disc or RNFL abnormalities consistent with glaucoma as detailed above,
`inability of patient to perform visual field testing, unreliable/uninterpretable visual field test results, or
`visual fields not performed yet
`
`PATIENT POPULATION
`The patient population consists of adults with open anterior chamber angles and with demonstrated
`optic nerve or RNFL damage, with or without corresponding visual field loss.
`
`CLINICAL OBJECTIVES
`(cid:139) Document the status of optic nerve structure and function on presentation
`(cid:139) Estimate an IOP below which further optic nerve damage is unlikely to occur (see discussion of
`Target Intraocular Pressure for Patients with POAG in the Care Process section)
`(cid:139) Attempt to maintain IOP at or below this target level by initiating appropriate medical and/or surgical
`intervention(s)
`(cid:139) Monitor the structure and function of the optic nerve for further damage and adjust the target IOP to a
`lower level if deterioration occurs
`(cid:139) Minimize the side effects of treatment and their impact on the patient’s vision, general health, and
`quality of life
`(cid:139) Educate and involve the patient and appropriate family members/caregivers in the management of the
`disease
`
`BACKGROUND
`
`PREVALENCE
`Primary open-angle glaucoma is a significant public health problem. It is estimated that 45 million
`people in the world have open-angle glaucoma (OAG).9 Glaucoma (both open-angle and angle-
`closure) is the second leading cause of blindness worldwide, with approximately 8.4 million people
`blind from glaucoma.9 Overall in 2004, the prevalence of POAG for adults aged 40 and older in the
`United States was estimated to be about 2%.10 Open-angle glaucoma affects an estimated 2.2 million
`people in the United States, and that number is likely to increase to 3.3 million in 2020 as the
`population ages.11,12 However, large differences exist in the prevalence of glaucoma among different
`ethnoracial groups (see Table 1 and Figure 1). Overall, there appears to be a threefold higher
`prevalence of OAG in African Americans relative to non-Hispanic whites in the United States.10,13 It
`is also the leading cause of blindness in African Americans.13 Further, the prevalence of OAG is even
`higher in Afro-Caribbeans relative to African Americans. Recent evidence on Hispanics/Latinos
`suggests that they have high prevalence rates of OAG that are comparable to the prevalence rates for
`African Americans.14 An analysis of claims data from a large U.S.-based managed care plan suggests
`that the prevalence of OAG among Asian Americans is comparable to the prevalence among Latinos
`and is higher than that of non-Hispanic white Americans.15
`
`P50
`
`

`

`TABLE 1 PREVALENCE (%) OF DEFINITE OPEN-ANGLE GLAUCOMA
`Study
`Ethnoracial Group
`
`Baltimore Eye Study16
`Barbados Eye Study17
`Los Angeles Latino Eye
`Study14
`Proyecto Vision Evaluation
`Research18
`Baltimore Eye Study16
`Blue Mountains Eye Study19
`Visual Impairment Project20
`Beaver Dam Eye Study21
`Roscommon22
`
`African American
`Afro-Caribbean
`Latino
`
`Latino
`
`NHW
`NHW
`NHW
`NHW
`NHW
`
`40–49
`1.3
`1.4
`1.3
`
`0.5
`
`0.2
`
`0.5
`
`0.4*
`
`50–59
`4.2
`4.1
`2.9
`
`0.6
`
`0.3
`
`1.5
`
`0.7
`
`Primary Open-Angle Glaucoma PPP:
`Prevalence
`
`Age-Specific Prevalence
`
`Age Groups (yrs)
`60–69
`70–79
`6.2
`8.9
`6.7
`14.8
`7.4
`14.7
`
`1.7
`
`1.5
`1.3
`4.5
`
`1.8
`
`5.7
`
`3.3
`4.7
`8.6
`
`3.2
`
`80+
`12.9
`23.2
`21.8
`
`12.6
`
`1.94
`11.4
`9.9
`
`3.1
`
`Total
`5.0
`6.8
`4.7
`
`2.0
`
`1.4
`3.0
`3.4
`2.1
`1.9
`
`NHW = non-Hispanic white
`NOTE: The studies reporting prevalence used different definitions of disease; therefore, caution should be exercised when comparing
`these studies.
`* The study combined ages 40–59 into one group.
`Adapted with permission from Varma R, Ying-Lai M, Francis B, et al, Los Angeles Latino Eye Study Group. Prevalence of open-angle
`glaucoma and ocular hypertension in Latinos: the Los Angeles Latino Eye Study. Ophthalmology 2004;111:1445.
`
`FIGURE 1. Comparison of age-specific prevalence of open-angle glaucoma in Latinos (Los Angeles Latino Eye Study
`[LALES]), African Americans/blacks and non-Hispanic whites (the Baltimore Eye Study)16
`* The data shown from the Los Angeles Latino Eye Study is from a different study.
`Adapted with permission from Varma R, Ying-Lai M, Francis B, et al, Los Angeles Latino Eye Study Group. Prevalence of open-angle
`glaucoma and ocular hypertension in Latinos: the Los Angeles Latino Eye Study. Ophthalmology 2004;111:1446.
`
`P51
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`

`

`Primary Open-Angle Glaucoma PPP
`
`RISK FACTORS
`The findings of epidemiological investigations and clinical trials provide a framework for assessing
`the risk factors associated with POAG. Numerous studies have identified risk factors associated with
`POAG:
`(cid:139) Higher IOP7,8,17-19,21,23-28
`(cid:139) Older age8,16,23,25,26,29,30
`(cid:139) Family history of glaucoma26,31
`(cid:139) African race or Latino/Hispanic ethnicity
`(cid:139) Thinner central cornea8,23,32
`(cid:139) Lower ocular perfusion pressure31,33,34
`(cid:139) Type 2 diabetes mellitus35-38
`(cid:139) Myopia34,39-41
`(cid:139) Lower systolic and diastolic blood pressure31
`(cid:139) Disc hemorrhage42-46
`(cid:139) Larger cup-to-disc ratio8,23
`(cid:139) Higher pattern standard deviation on threshold visual field testing28,47
`
`Intraocular Pressure
`A number of population-based studies have demonstrated that the prevalence of POAG7,17-19,21,24,27,48
`increases as the level of IOP increases (see Figure 2). In the Baltimore Eye Survey, at an IOP of 30
`mmHg, nearly 7% of Caucasians and 25% of African Americans had POAG.24 These studies provide
`strong evidence that IOP plays an important role in the optic neuropathy of POAG. Furthermore,
`studies have demonstrated that reduction in the level of IOP decreases the risk of visual field
`progression in OAG (see Table 2).23,49-54 In addition, treated eyes that have a greater IOP fluctuation
`may be at increased risk of progression, although this has not been shown consistently.55-60
`In spite of the relationship between the level of IOP and POAG, there is great interindividual
`variation in the susceptibility of the optic nerve to IOP-related damage. Population-based
`studies indicate that a variable proportion of patients with IOP greater than 21 mmHg (Northern
`Italy [13%],61 Los Angeles [18%],14 Arizona [20%],18 Blue Mountains [25%],19 Melbourne
`[39%],20 Baltimore [45%],16 Rotterdam [61%],7 Barbados [71%]34) have glaucomatous optic
`nerve damage.24 This suggests that an IOP level of greater than 21 mmHg is an arbitrarily
`defined level and highlights the poor predictive value of utilizing a specific IOP cutoff as a
`measure for screening or diagnosis of POAG.
`
`FIGURE 2. The relationship between prevalence of open-angle glaucoma and intraocular pressure (measured using
`Goldmann applanation tonometry) in Latinos (n=5970) in the Los Angeles Latino Eye Study.
`Adapted with permission from Francis B, Varma R, Chopra V, et al, Los Angeles Latino Eye Study Group. Intraocular pressure,
`central corneal thickness, and prevalence of open