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Key papers in glaucoma

Jorge Rivera Vélez, MD UPR-School of Medicine Ophthalmology. Key papers in glaucoma. Ocular Hypertension Treatment Study. Purpose Role of medical treatment in ocular hypertensive patients Natural history Risk factors to develop POAG Description

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Key papers in glaucoma

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  1. Jorge Rivera Vélez, MD UPR-School of Medicine Ophthalmology Key papers in glaucoma

  2. Ocular Hypertension Treatment Study • Purpose • Role of medical treatment in ocular hypertensive patients • Natural history • Risk factors to develop POAG • Description • Randomly assigned to observation vs. medical regimen • 5 year follow-up • Outcome measures: • Visual field loss • Progressive optic disc damage • Ocular hypertensive patients w/o nerve or visual field damage

  3. Ocular Hypertension Treatment Study • Effects of therapy • POAG 4.4% in medication group • POAG 9.5% in observation group • Risk halved when IOP ≤ 24 mm Hg or 20% reduction from baseline.

  4. Ocular Hypertension Treatment Study • Predictors of progression to POAG • Older age • Race (African American) • Larger vertical or horizontal cup-disc ratio • Higher intraocular pressure • Greater pattern standard deviation • Thinner central corneal measurement

  5. Ocular Hypertension Treatment Study • Conclusions • Medication is effective in delaying or preventing onset of POAG in ocular hypertensive patients

  6. Ocular Hypertension Treatment Study • Publications • Higginbotham EJ, Gordon MO, Beise JA, Drake MV, Bennett GR, Wilson MR, Kass MA, for the Ocular Hypertension Treatment Study Group: The Hypertension Treatment Study: Topical medication delays or prevents primary open-angle glaucoma in African American individuals.  Ophthalmology  122: 813-820, 2004   • Gordon MO, Beiser JA, Brandt JD, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miller JP, Parrish II RK, Wilson MR, Kass MA, for the Ocular Hypertension Treatment Study Group: The Ocular Hypertension Treatment Study: Baseline Factors that Predict the Onset of Primary Open-Angle Glaucoma  Arch Ophthalmol  120: 714-720, 2002   • Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, Keltner JL, Miler JP, Parrish II RK, Wilson MR, Gordon MO, for the Ocular Hypertension Treatment Study Group: 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  120: 701-713, 2002   • Palmerg P: Answers from the Ocular Hypertension Treatment Study (editorial)  Arch Ophthalmol  120: 829-830, 2002   • Keltner JL, Johnson CA, Quigg JM, Cello KE, Kass MA, Gordon MO, for the Ocular Hypertension Treatment Study Group: Confirmation of visual field abnormalities in the Ocular Hypertension Treatment Study  Arch Ophthalmol  118: 1187-1194, 2000   • Kass MA: The Ocular Hypertension Treatment Study.  J Glaucoma  3: 97-100, 1994  

  7. Collaborative Initial Glaucoma Treatment Study • Purpose • Compare medications vs. trabeculectomy in newly diagnosed POAG • Description • Randomly assigned to medication regimen vs. trabeculectomy • Medication group • Beta-blocker +/- other meds ALT Trabeculectomy • Surgery group • TrabeculectomyALT  meds • 5 year follow-up • Quality of life assessment • Patients with high IOP with damage to ON or VF

  8. Collaborative Initial Glaucoma Treatment Study • Results • Medical group: 17-18 mm Hg (drop of 35% from baseline) • Surgery group: 14-15 mm Hg (drop of 48% from baseline) • Visual fields preservation similar in both in 5 years • Visual acuity worst in surgical group (cataracts) • Quality of life: both groups satisfied w results

  9. Collaborative Initial Glaucoma Treatment Study • Conclusions • Longer follow-up is needed before specific treatment recommendations can be made in a chronic disease like glaucoma.

  10. Collaborative Initial Glaucoma Treatment Study • Publications • Mills RP, Janz NK, Wren PA, Guire KE, CIGTS Study Group: Correlation of visual field with quality-of-life measures at diagnosis in the Collaborative Initial Glaucoma Treatment Study (CIGTS). Journal of Glaucoma 10: 192-8, 2001. • Lichter PR, Musch DC, Gillespie BW, Guire KE, Janz NK, Wren PA, Mills RP, CIGTS Study Group: Interim Clinical Outcomes in the Collaborative Initial Glaucoma Treatment Study (CIGTS) Comparing Initial Treatment Randomized to Medications or Surgery. Ophthalmology 108: 1943-53, 2001. • Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, The CIGTS Group: Quality of life in diagnosed glaucoma patients. The Collaborative Initial Glaucoma Treatment Study. Ophthalmology 108: 887-898, 2001. • Janz NK, Wren PA, Lichter PR, Musch DC, Gillespie BW, Guire KE, Mills RP, CIGTS Study Group: The Collaborative Initial Glaucoma Treatment Study (CIGTS): Interim Quality of Life Findings Following Initial Medical or Surgical Treatment of Glaucoma. Ophthalmology 108: 1954-65, 2001. • Musch DC, Lichter PR, Guire KE, Standardi CL, CIGTS Investigators: The Collaborative Initial Glaucoma Treatment Study (CIGTS): Study design, methods, and baseline characteristics of enrolled patients. Ophthalmology 106: 653-62, 1999. • Janz N, Wren PA, CIGTS Study Group: Implementing quality of life in a clinical trial, in Anderson DR, Drance SM (eds). The Collaborative Initial Glaucoma Treatment Study. Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, 45-62, 1996. • Lichter PR, Mills RP, CIGTS Study Group: Quality of life study - determination of progression, in Anderson DR, Drance SM (eds). Encounters in Glaucoma Research 3: How to Ascertain Progression and Outcome, Amsterdam, Kugler Publications, 149-163, 1996.

  11. Early Manifest Glaucoma Trial • Purpose • Evaluate effect of lowering IOP in progression of POAG • Natural history • Description • Randomly assigned to Betaxolol+ ALT vs. no treatment • First study to offer control group with glaucoma • 255 patients • 4 year follow-up • Treatment group  Xalatan if IOP > 25 • Control group  Xalatan if IOP > 35 • Patients with newly detected, untreated POAG

  12. Early Manifest Glaucoma Trial • Results • At 48 months of follow up: • 30% progression in treated • 49% progression in control • Median time for progression: • 48 months in control • 66 months in treated

  13. Early Manifest Glaucoma Trial • Conclusions • Considerable beneficial effects of treatment that significantly delayed progression

  14. Early Manifest Glaucoma Trial • Publications • Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M, for the Early Manifest Glaucoma Trial Group: Reduction of intraocular pressure and glaucoma progression: Results from the Early Manifest Glaucoma Trial . Arch Ophthalmol 120: 1268-1279, 2002. • Leske MC, Heijl A, Hyman L, Bengtsson B, The Early Manifest Glaucoma Trial Group: Early Manifest Glaucoma Trial: Design and baseline data. Ophthalmology 106: 2144-2153, 1999.

  15. Advanced Glaucoma Intervention Study • Purpose • Asses outcome of sequences of intervention (trabeculectomy/ ALT) in eyes that failed medical treatment • Description • Randomly assign to: • Trabeculectomy ALT  Trabeculectomy • ALT  Trabeculectomy  Trabeculectomy • Antifibrotics agents only if previous surgery • Suplemented w medical tx as needed • 789 eyes • 7 year follow-up • Outcome measure: decrease in VF or VA secondary to glaucoma • Patients with POAG not controlled with medications

  16. Advanced Glaucoma Intervention Study • Results • Best sequence in blacks: ATT • ATT: 28% eyes decreased vision in 7 years • TAT: 37% eyes decreased vision in 7 years • Best sequence in whites: TAT • TAT: 31% eyes decreased vision in 7 years • ATT: 35% eyes decreased vision in 7 years • Disease progression close to zero only if: • IOP below 18 at all visits • Mean IOP 12.3 • Similar rate of cataracts after trabeculectomy in black and whites (78%) • ALT failure: younger age, high pre-laser IOP • Trabeculectomy failure: younger age, high pre-op IOP, DM, post-op inflammation

  17. Advanced Glaucoma Intervention Study • Conclusions • Black patients with advanced glaucoma should begin treatment program that starts with laser surgery • White patients with advanced glaucoma should begin treatment that starts with trabeculectomy

  18. Advanced Glaucoma Intervention Study • Publications • http://spitfire.emmes.com/study/agi/resources/agis-bib.pdf

  19. Glaucoma Laser Trial and Follow up Study • Purpose • Compare ALT safety and efficacy with medical tx in POAG • Description • Each patient randomized to ALT in one eye and topical medication in the other eye • 271 patients in GLT • 203 (of 271) in GLTFS, followed for 7 years • If IOP not reduced sufficiently (20% baseline) in either group: • Medication change in medication group • Start medication in ALT group • Patients w IOP at least 22 and ON damage in at least one eye.

  20. Glaucoma Laser Trial and Follow up Study • Results • ALT treated eyes had 1.2mmHG greater reduction in IOP and 0.6 dB greater improvement in VF • Conclusions • Initial treatment with ALT was at least as efficacious as initial treatment with topical medication

  21. Glaucoma Laser Trial and Follow up Study • Publications • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT): 6. Treatment group differences in visual field changes. Am J Ophthalmol 120: 10-22, 1995. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT) and Glaucoma Laser Trial Followup Study: 7. Results. Am J Ophthalmology 120: 718-731, 1995. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT): 5. Subgroup differences at enrollment. Ophthalmic Surg 24: 232-241, 1993. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT): 3. Design and methods. Controlled Clinical Trials 12: 504-524, 1991. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial: 4. Contra-lateral effects of timolol on the intraocular pressure of eyes treated with ALT. Ophthalmic Surg 22: 324-329, 1991. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT): 2. Results of argon laser trabeculoplasty vs. topical medicines. Ophthalmology 97: 1403-1413, 1990. • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial: 1. Acute effects of argon laser trabeculoplasty on intraocular pressure. Arch Ophthalmol 107: 1135-1142, 1989.

  22. Fluorouracil Filtering Surgery Study • Purpose • Success rate of standard trabeculectomy vs. trabeculectomyw 5-FU • Evaluate adverse effects of 5-FU injections • Description • Randomized to receive 5-FU injections vs. standard post-surgical care after trabeculectomy • 5-FU regimen • Twice daily the first week • Once daily the second week • 21 total injections • 213 patients • 5 years follow up • Outcome measures: no reoperation and IOP under 21 • Patients w IOP > 21 on MMT and aphakic or previous filtering surgery

  23. Fluorouracil Filtering Surgery Study • Results • Improved surgical control using 5-FU in patients at high risk for failure • Success rate of trabeculectomy at 5 years: • 5-FU group: 48% • Standard group: 21% • No difference in visual acuity over 5 years • Regardless of group controlled IOP = less visual acuity loss • Late-onset leak of filtering bleb • 9% of 5-FU group • 2% of standard group • High pre-op IOP + post-op hypotony = choroidal effusions and hemorrhages • Prevent with tight or releasable sutures

  24. Fluorouracil Filtering Surgery Study • Conclusions • Use of 5-FU after trabeculectomy recommended in eyes with prior cataract surgery or unsuccesful filtering surgery • Preservation of visual function associated with IOP control

  25. Fluorouracil Filtering Surgery Study • Publications • The Fluorouracil Filtering Surgery Study Group: Five-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol 121: 349-366, 1996. • The Fluorouracil Filtering Surgery Study Group: Three-year follow-up of the Fluorouracil Filtering Surgery Study. Am J Ophthalmol 115: 82-92, 1993. • The Fluorouracil Filtering Surgery Study Group: Risk factors for suprachoroidal hemorrhage after filtering surgery. Am J Ophthalmol 113: 501-507, 1992. • The Fluorouracil Filtering Surgery Study Group: Fluorouracil Filtering Surgery Study one-year follow-up. Am J Ophthalmol 108: 625-635, 1989.

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