Present relevant clinical findings of four landmark glaucoma trials OHTS, EMGT, CNTGS and CIGTS.

Transcription

1 Course title: The Glaucoma Compass Course length: 1 hour +/- 31 slides Corse Description: Even with the technology and available information, glaucoma decision making can still be confusing. How should clinicians approach glaucoma patient management and decision-making? Population-based randomized studies help improve disease knowledge, and findings often provide a compass for the treatment and management of disease entities. This case-based course features four Optometric Glaucoma Society members sharing their knowledge on how critical findings from landmark studies guide us in navigating our path to decision making in glaucoma patient management. Course Objectives: Present relevant clinical findings of four landmark glaucoma trials OHTS, EMGT, CNTGS and CIGTS. Discuss how population based, randomized studies (OHTS, EMGT, CNTGS and CIGTS) expand disease knowledge and influence management decisions in glaucoma patients. Present sample cases where OHTS, EMGT, CNTGS and CIGTS clinical findings provide guidance in patient management. Course Faculty: Agustin Gonzalez, OD, FAAO- VA Outpatient Clinic, Ft Worth, Tx. Austin Lifferth, OD, FAAO- VA Outpatient Clinic, Villages, Fl. Andrew Rixon, OD, FAAO- Memphis VA Medical Center, Tn. Brian Mahoney, OD FAAO- Wilmington VA Medical Center, De. Course Concept: This course aims to improve clinician confidence in decision making by providing trial study based clinical guidance for glaucoma patient management. Reviewers Please Note: This outline includes: 1. Outline (topic/time/slide oriented structure) 2. Tentative slide deck 3. Selected references. The outline is intent for reviewers to obtain a sense of the sequence of topics and time devoted to coverage. Written permission / authorization has been obtained from GONE project for reproduction and available upon request. NOTE ALL slides will be referenced, references will be placed on slides upon acceptance.

2 Course Outline: 1. Introduction, Disclosures - Why this course 2. Case # 1 - Ocular Hypertension Treatment Study (OHTS) a. Does treating abnormally elevated intraocular pressure (IOP) with topical medications delays or prevents the onset of glaucomatous damage? b. Identify baseline demographic and clinical risk factors for developing primary openangle glaucoma (POAG). i. 10 yr follow-up ii. 1,636 patients with ocular hypertension iii. ages 40 to 80 iv. normal visual fields v. normal optic discs vi. untreated IOP of 24 to 32 mmhg in one eye, 21 to 32 mmhg in fellow eye vii. randomized: observation or a stepped topical medical regimen viii. patients in observation group offered medication after 7.5 years of follow-up c. Main outcome measure: visual fields and stereoscopic optic disc photographs d. - Treatment delays onset of glaucoma. e. - Treating abnormally elevated intraocular pressure (IOP) with topical medications delays or prevents the onset of glaucomatous damage. f. - Treatment with topical antiglaucoma medication decreased IOP by 20 % and reduced the incidence of glaucoma by 60 % compared with observation. g. Take risk categories into account. i. - high, medium and low risk ii. - factors: age, health status, life expectancy and patient preference. h. Observation vs treatment in some patients. i. - Should ocular hypertensives be treated in an attempt to prevent the onset of glaucoma? ii or 20 % of people with ocular hypertension eventually develop glaucoma 3. Case # 2 - Early Manifest Glaucoma Trial a. What happens? Compare the effect of IOP-lowering treatment vs. observation on the progression of early, newly detected untreated glaucoma b. What is the magnitude of any treatment? i. - 7 to 11 years of follow-up ii patients, aged 50 to 80, with early-stage glaucoma in at least one eye iii. - median visual field mean deviation of 4 db and median IOP of 20 mmhg iv. - Randomized to initial treatment with a selective beta-blocker and ALT or left untreated until signs of progression appeared c. Main outcome measure: visual fields or optic disc photographs d. - Follow progression closely e. - Reset IOP target as needed

3 f. - IOP and testing visual fields g. - Go the extra mmhg h. - Recognize exfoliation as a risk i. Treat IOP Early, Follow Progress Closely 4. Case # 3 - Collaborative Normal Tension Glaucoma Study a. Does lowering IOP help in managing NTG? i. 5+ yrs. follow-up ii. 260 patients with NTG iii. either progressive NTG or NTG with field defects impinging on the point of fixation iv. Randomized to no therapy or IOP lowering by 30% v. (pilocarpine or carbonic anhydrase inhibitor), laser, filtering surgery or a combination b. Main outcome measure: change from a three-field baseline in five of six follow-up visual fields c. - IOP plays a role in NTG d. - Changes in visual field thresholds are affected by cataract e. - Natural history of NTG f. - Progressive vs. no progressive g. - Surgery may not be necessary h. Assess progression closely 5. Case # 4 - Collaborative Initial Glaucoma Treatment Study a. Is it better for newly diagnosed open-angle glaucoma (primary, pigmentary, or pseudo exfoliative) to be treated by medications or by immediate filtration surgery? i. 5 to 9 yrs. follow-up ii. 607 patients, aged 25 to 75, newly diagnosed open-angle glaucoma (OAG) iii. IOP of 20 mmhg or greater iv. optic nerve damage and/or visual field loss in one or both eyes v. Randomized to initial treatment with stepped topical medication vs. trabeculectomy b. Main outcome measure: visual fields c. Treatment effect validated i. pressure lowering is beneficial in glaucoma treatment for all clinical situations ii. Every 1 mmhg reduction matters iii. Disease progression is variable iv. Mean IOP, not fluctuation, is what matters v. Findings are consistent with OHTS and CNTG studies d. Discuss fear of blindness e. Consider surgery first - filtering surgery is easier before eyedrops are used

4 f. Major surgical complications are few g. Keep IOP steady 6. CLOSING REMARKS - The GONE Project - Role of PPP and CPG, - Mentorship, SIG s

5 Slide 1 The Glaucoma Compass Slide 2 Why this course? How should we approach our glaucoma management and decisionmaking? Population based randomized studies - Disease knowledge - Guidance 4 cases showing how landmark glaucoma studies provide guidance in the management of glaucoma patients. Talking points: We often get asked how do we got started treating glaucoma Talk about navigating and having a compass Discussion of why this course is relevant and inception. Slide 3 Course Objectives: Discuss relevant clinical findings of 4 landmark glaucoma trials (OHTS, EMGT, CNTGS and CIGTS) Explain how these 5 landmark glaucoma trials (OHTS, EMGT, CNTGS and CIGTS) help guide our management of glaucoma patients. Present cases where population based, longitudinal trials clinical findings provide disease entity knowledge and guidance in the management of glaucoma patients. Explain how the presentation will be structured 5 cases 5 take home points GONE project

6 Slide 4 Disclosures Agustin Gonzalez, OD, FAAO VA Outpatient Clinic, Ft Worth, Tx. Austin Lifferth, OD, FAAO VA Outpatient Clinic,Villages, Fl. Andrew Rixon, OD, FAAO Memphis VA Medical Center, Tn. GONE project data and ONH reproductions used with GONE- Brian Mahoney, OD FAAO Project authorization. Wilmington VA Medical Center, De. Disclosures one speaker Slide 5 Case # 1 Andrew Rixon, OD Patient info here Case # 1 Drew will fill in data and discuss Slide 6 PATIENT TESTS:

7 Slide 7 Slide 8 Ocular Hypertension Treatment Study (OHTS) - 10 years of follow-up - 1,636 patients with ocular hypertension ages 40 to 80 - normal visual fields - normal optic discs - untreated IOP of 24 to 32 mmhg in one eye, 21 to 32 mmhg in fellow eye - randomized to - observation - topical medical regimen; Main outcome measure: visual fields and stereoscopic optic disc photographs 1. Demonstrate that treating abnormally elevated intraocular pressure (IOP) with topical medications delays or prevents the onset of glaucomatous damage. 2. Identify baseline demographic and clinical risk factors for developing primary open-angle glaucoma (POAG). Slide 9 OHTS - findings Treatment delays onset of glaucoma. - treating abnormally elevated intraocular pressure (IOP) with topical medications delays or prevents the onset of glaucomatous damage. - treatment with topical antiglaucoma medication decreased IOP by 20 % and reduced the incidence of glaucoma by 60 % compared with observation.

8 Slide 10 OHTS take home Take home points from OHTS Take risk categories into account. - high, medium and low risk - factors: age, health status, life expectancy and patient preference. Observation vs treatment in some patients. - Should ocular hypertensives be treated in an attempt to prevent the onset of glaucoma? - 10 or 20 % of people with ocular hypertension eventually develop glaucoma Slide 11 Case # 2 Austin Lifferth, OD Patient info here Case # 2 Austin will fill in data and discuss Slide 12 PATIENT TESTS:

9 Slide 13 Slide 14 Early Manifest Glaucoma Trial - 7 to 11 years of follow-up patients, aged 50 to 80, with earlystage glaucoma in at least one eye - median visual field mean deviation of 4 db and median IOP of 20 mmhg - Randomized to initial treatment with a selective beta-blocker and ALT or left untreated until signs of progression appeared Main outcome measure: visual fields or optic disc photographs 1. To compare the effect of IOPlowering treatment versus observation on the progression of early, newly detected untreated glaucoma 2. To assess the magnitude of any treatment effect. Slide 15 EMGT findings - pressure lowering is beneficial in glaucoma treatment, in all clinical situations - findings are consistent with OHTS and CNTG studies. - Every 1 mmhg reduction matters. 1 mmhg of IOP reduction was associated with a risk reduction of 10 to 13 percent - Disease progression is variable. The rate of glaucoma progression is variable and difficult to predict.

10 Slide 16 EMGT findings - Factors: age, initial eye pressure, degree of glaucoma damage - Most patients will eventually progress to some extent Is this patient progressing at a speed that is of concern during his or her remaining lifetime, or is change occurring so slowly that it doesn t matter? - Mean IOP, not fluctuation, is what matters Slide 17 EMTG take home points EMGT take home - Follow progression closely - Reset IOP target as needed - IOP and testing visual fields - Go the extra mmhg - Recognize exfoliation as a risk Treat IOP Early, Follow Progress Closely Slide 18 Case # 3 Brian Mahoney, OD Patient info here Case # 3 Brian will fill in data and discuss

11 Slide 19 PATIENT TESTS: Slide 20 Slide 21 Collaborative Normal Tension Glaucoma Study - 5+ yrs. follow-up Does lowering IOP help in managing NTG? patients with NTG - either progressive NTG or NTG with field defects impinging on the point of fixation - Randomized to - no therapy - IOP lowering by 30% (pilocarpine or carbonic anhydrase inhibitor), laser, filtering surgery or a combination Main outcome measure: change from a threefield baseline in five of six follow-up visual fields

12 Slide 22 CNTGS - findings IOP plays a role in NTG Changes in visual field thresholds are affected by cataract Natural history of NTG Slide 23 NTGS take home points CNTGS take home Progressive vs. no progressive Surgery may not be necessary Assess progression closely 30% IOP reduction reduces risk from 35% to 12 % Slide 24 Case # 4 Agustin Gonzalez, OD Patient info here Case # 2 Agustin will fill in data and discuss

13 Slide 25 PATIENT TESTS: Slide 26 Collaborative Initial Glaucoma Treatment Study - 5 to 9 yrs. follow-up patients, aged 25 to 75, newly diagnosed open-angle glaucoma (OAG) - IOP of 20 mmhg or greater - optic nerve damage and/or visual field loss in one or both eyes Randomized to initial treatment with stepped topical medication or trabeculectomy Main outcome measure: visual fields Compare the effect of IOP-lowering treatment vs observation on the progression of early, newly detected untreated glaucoma To assess the magnitude of any treatment effect whether patients with newly diagnosed openangle glaucoma (primary, pigmentary, or pseudoexfoliative) are better treatedby initial treatment with medications or by immediate filtration surgery Slide 27

14 Slide 28 CIGTS - findings Treatment effect validated pressure lowering is beneficial in glaucoma treatment for all clinical situations Every 1 mmhg reduction matters Disease progression is variable Mean IOP, not fluctuation, is what matters Findings are consistent with OHTS and CNTG studies Slide 29 Case # 5 take home points CIGTS take home Discuss fear of blindness Consider surgery first - filtering surgery is easier before eyedrops are used Major surgical complications are few Keep IOP steady Slide 30 GONE project Outside - Disk size - Disk shape - PPA - Disk Tilt Inside - Cup depth - Cup shape - Cup to Disk ratio Confirmation - NFL defect - Hemorrhages Diagnosis Low Medium High Talking points: The importance of critical ONH observation Undiagnosed glaucoma estimated at 50% GONE project as tool of self assessment and improvement

15 Slide 31 Slide 32 THE END Slide 33 Additional slides

16 Slide 34 Case # 4 Patient info here Case # 2 Drew will fill in data and discuss Slide 35 Advanced Glaucoma Intervention Study Eight to 11 years of follow-up 591 patients (789 eyes), ages with advanced POAG, on maximum tolerated medical therapy, baseline VA score 56 or better in the study eye, baseline AGIS visual field score of 1 to 16 Randomized to: ALT-trabeculectomy-trabeculectomy (ATT) trabeculectomy-alt-trabeculectomy (TAT) examine the long-term outcomes of two different surgical sequences for treatment of advanced glaucoma 1. ALT-trabeculectomytrabeculectomy (ATT) 2. trabeculectomy-alttrabeculectomy (TAT) Main outcome measures: sustained decrease of visual field and sustained decrease of visual acuity Slide 36

17 Slide 37 AIGS - Findings: Reducing IOP slows visual field loss Surgery will help achieved stability Race affected outcomes Slide 38 Case # 4 take home points AIGS - Take Home Take race into account

18 Some selected references: Weinreb RN, Aung T, Medeiros FA. The Pathophysiology and Treatment of Glaucoma A Review. JAMA.2014;311(18): doi: /jama Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish RK, Wilson MR, Gordon MO,. The Ocular Hypertension Treatment Study A Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-Angle Glaucoma. Arch Ophthalmol.2002;120(6): doi: /archopht Gordon MO, Kass MA,. The Ocular Hypertension Treatment Study Design and Baseline Description of the Participants. Arch Ophthalmol. 1999;117(5): doi: /archopht Hyman L, Heijl A, Leske MC, Bengtsson B, Yang Z,. Natural History of Intraocular Pressure in the Early Manifest Glaucoma TrialA 6-Year Follow-up. Arch Ophthalmol. 2010;128(5): doi: /archophthalmol Leske MC, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E,. Factors for Glaucoma Progression and the Effect of Treatment The Early Manifest Glaucoma Trial. Arch Ophthalmol. 2003;121(1): doi: /archopht Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M,. Reduction of Intraocular Pressure and Glaucoma Progression Results From the Early Manifest Glaucoma Trial. Arch Ophthalmol. 2002;120(10): doi: /archopht Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126: Collaborative Normal-Tension Glaucoma Study Group. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am J Ophthalmol 1998;126: Drance S, Anderson DR, Schulzer M, Collaborative Normal-Tension Glaucoma Study Group. Risk factors for progression of visual field abnormalities in normal-tension glaucoma. Am J Ophthalmol 2001;131: The Advanced Glaucoma Intervention Study (AGIS): The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators. Am J Ophthalmol 200;130:4: Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP; the CIGTS study Group. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108:11: Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP, the CIGTS Study Group. The Collaborative Initial Glaucoma Treatment Study. Ophthalmology 2001;108:11: GONE-PROJECT.COM