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Landmark glau studies

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Landmark glau studies

  1. 1. Monday, March 11, 13
  2. 2. Landmark Glaucoma Studies Cesar A. Perez Jr MD DPBO Clinical Associate Professor UP-PGH Philippine Glaucoma SocietyMonday, March 11, 13
  3. 3. Intro • Alphabet Soup • OHTS • CIGTS • TVT • EMGT • CNTGS • AGISMonday, March 11, 13
  4. 4. “Doctor, why do we need to put those expensive eye drops for glaucoma?”Monday, March 11, 13
  5. 5. OHTS • Ocular Hypertension Study - Aim: To determine if glaucoma drops delays or prevents glaucoma in ocular hypertensivesMonday, March 11, 13
  6. 6. OHTS • Ocular Hypertension Study - 1,636 patients - 10 years of follow-up - Main Outcome Measures: AVFs and stereoscopic optic disc photos Arch Ophthalmol 120: 701-713, 2002Monday, March 11, 13
  7. 7. OHTS Ocular Hypertension Study • Entry criteria: ages 40 to 80; normal visual fields and normal optic discs; untreated IOP of 24 to 32 mmHg in one eye, 21 to 32 mmHg in fellow eye • Initially randomized to: - observation - stepped topical medical regimenMonday, March 11, 13
  8. 8. OHTS Ocular Hypertension Study • KEY FINDINGS - First to demonstrate that lowering IOP delays/prevents glaucoma - Identified risk factors in developing POAGMonday, March 11, 13
  9. 9. OHTS Ocular Hypertension Study • First to demonstrate that lowering IOP delays/prevents glaucoma - treated group: 4.4% developed POAG - observation: 9.5%Monday, March 11, 13
  10. 10. OHTS Ocular Hypertension Study • Identified risk factors in developing POAG - IOP, age, central corneal thickness, vertical cup to disc ratio, PSD - established low-, mid- to high-risk groupsMonday, March 11, 13
  11. 11. OHTS Ocular Hypertension Study • Lessons for Clinicians - Take risk categories into account - Consider observation before treatment in some patientsMonday, March 11, 13
  12. 12. OHTS Ocular Hypertension Study • Lessons for Clinicians - Treat those with: ‣ older age ‣ high cup to disk ratio ‣ high PSD in AVFs ‣ thin corneasMonday, March 11, 13
  13. 13. “Doctor, I just learned I have glaucoma, which is better - drops or surgery?”Monday, March 11, 13
  14. 14. CIGTS Collaborative Initial Glaucoma Treatment Study • Trabeculectomy vs drugs for initial therapy - Effect on early diagnosed open-angle glaucoma of treatment with topical meds or trabeculectomy Ophthalmology 106: 653-62, 1999Monday, March 11, 13
  15. 15. CIGTS • Collaborative Initial Glaucoma Treatment Study - 607 patients - 5-9 years of follow-up - Main Outcome Measure: AVFsMonday, March 11, 13
  16. 16. CIGTS Collaborative Initial Glaucoma Treatment Study • Entry criteria: IOP of 20 mmHg or greater; optic nerve damage and / or visual field loss in one or both eyes • Randomized initial treatment: - with stepped topical medication - trabeculectomyMonday, March 11, 13
  17. 17. CIGTS Collaborative Initial Glaucoma Treatment Study • KEY FINDINGS - Aggressive IOP targets yield results - Quality of Life measuredMonday, March 11, 13
  18. 18. CIGTS Collaborative Initial Glaucoma Treatment Study • Aggressive IOP targets yield results - 35% reduction from medication - 48% reduction from surgeryMonday, March 11, 13
  19. 19. CIGTS Collaborative Initial Glaucoma Treatment Study • Lessons for Clinicians - Consider surgery first in patients with moderate or advanced disease - Keep IOP steady - Major surgical complications are fewMonday, March 11, 13
  20. 20. CIGTS Collaborative Initial Glaucoma Treatment Study • Lessons for Clinicians - Surgery resulted in: ‣ lower IOP ‣ more cataracts ‣ more ocular side effects ‣ initial decreased vision ‣ initial decreased visual fieldMonday, March 11, 13
  21. 21. “Doctor, I stopped my glaucoma medications, what will happen to my eyes?”Monday, March 11, 13
  22. 22. EMGT Early Manifest Glaucoma Trial • Treat IOP early, follow progress closely Arch Ophthalmol 120: 1268-1279, 2002.Monday, March 11, 13
  23. 23. EMGT • Early Manifest Glaucoma Trial - 255 patients - 7 to 11 years of follow-up - Main Outcome Measures: AVFs and optic disc photosMonday, March 11, 13
  24. 24. EMGT Early Manifest Glaucoma Trial • Entry criteria: 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 - left untreated until signs of progression appearedMonday, March 11, 13
  25. 25. EMGT Early Manifest Glaucoma Trial • KEY FINDINGS - Treatment effect validated - Every 1 mmHg reduction matters - Disease progression is variable - Mean IOP is vitalMonday, March 11, 13
  26. 26. EMGT Early Manifest Glaucoma Trial • Lessons for clinicians - Follow progression closely; reset target as needed - Exfoliation as a risk factor - Strive for the lower IOPMonday, March 11, 13
  27. 27. EMGT Early Manifest Glaucoma Trial • Lessons for clinicians - Aggressive treatment if: ‣ pseudoexfoliation ‣ bilateral disease ‣ older patient ‣ higher IOP ‣ worse mean deviation ‣ disc hemorrhageMonday, March 11, 13
  28. 28. “Doctor, why do I have glaucoma if my pressure is 20 mmHg?”Monday, March 11, 13
  29. 29. CNTGS Collaborative Normal-Tension Glaucoma Study • IOP reduction important even for normotensives Curr Opin Ophthalmol. 2003;14(2):86-90.Monday, March 11, 13
  30. 30. CNTGS • Collaborative Normal-Tension Glaucoma Study - 260 patients - > 5 years of follow up - Main Outcome Measures: AVFMonday, March 11, 13
  31. 31. CNTGS Collaborative Normal-Tension Glaucoma Study • Entry criteria: eyes with either progressive NTG or NTG with field defects impinging on the point of fixation • Randomized to receive: • no therapy • IOP lowering by 30 percent with medication (pilocarpine or carbonic anhydrase inhibitor), laser, filtering surgery or a combinationMonday, March 11, 13
  32. 32. CNTGS Collaborative Normal-Tension Glaucoma Study • KEY FINDINGS - IOP plays a role in NTG - Cataract confounders - Over half of patients did not progress without treatment at 5 yearsMonday, March 11, 13
  33. 33. CNTGS Collaborative Normal-Tension Glaucoma Study • Lessons for Clinicians - Distinguish between progressive and non- progressive disease - Surgery may not be necessaryMonday, March 11, 13
  34. 34. CNTGS Collaborative Normal-Tension Glaucoma Study • Lessons for Clinicians - Aggressive treatment if: - female patient - presence of migraine - disc hemorrhagesMonday, March 11, 13
  35. 35. “Doctor, which treatment is better for my glaucoma - trabeculectomy or laser?”Monday, March 11, 13
  36. 36. AGIS Advanced Glaucoma Interventional Study • Aim: To assess the outcome of sequences of laser and surgical interventions in eyes that have failed on medical treatment Controlled Clinical Trials 15(4): 299-325, 1994.Monday, March 11, 13
  37. 37. AGIS • Advanced Glaucoma Interventional Study - 591 patients - 8-11 years of follow up - Main Outcome Measures: sustained decrease of visual field and visual acuityMonday, March 11, 13
  38. 38. AGIS Advanced Glaucoma Interventional Study • Entry criteria: patient 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 receive: • ALT > trabeculectomy > trabeculectomy (ATT) • trabeculectomy > ALT > trabeculectomy (TAT)Monday, March 11, 13
  39. 39. AGIS Advanced Glaucoma Interventional Study • KEY FINDINGS - Reducing IOP slows visual field loss - Many patients achieved stability - Race affected outcomesMonday, March 11, 13
  40. 40. AGIS Advanced Glaucoma Interventional Study • Lessons for clinicians - Take race into account when choosing therapy - Blacks should have laser first - Whites should have trabeculectomy firstMonday, March 11, 13
  41. 41. “Doctor, which surgery is better for my glaucoma - trabeculectomy or tube?”Monday, March 11, 13
  42. 42. TVT • Trabeculectomy vs Tube Study - 212 patients - 5 years of follow-up - Main Outcome Measures: IOP, VA, AVF, surgical complications, treatment failures Am J Ophthalmol. 2009;148(5):670-684.Monday, March 11, 13
  43. 43. TVT Trabeculectomy vs Tube Study • Entry criteria: prior cataract or glaucoma filtering surgery and uncontrolled glaucoma with IOP of 18 mmHg to 40 mmHg on maximum tolerated medical therapy • Randomized to receive: • either tube shunt surgery and/or • trabeculectomy with mitomycin C (MMC)Monday, March 11, 13
  44. 44. TVT Trabeculectomy vs Tube Study • KEY FINDINGS - Trab vs. shunt: no clear winner - Complications and failure ratesMonday, March 11, 13
  45. 45. TVT Trabeculectomy vs Tube Study • Lessons for Clinicians - Put tubes in armamentarium - Assess patient’s unique needsMonday, March 11, 13
  46. 46. Recap • Present glaucoma clinical practice guidelines have strong evidences • Identification of risk factors, degree of disease and quality of life is key • Customize treatmentMonday, March 11, 13
  47. 47. Thank you for your attention :)Monday, March 11, 13

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