Download - Landmark glau studies
Monday, March 11, 13
Landmark Glaucoma Studies
Cesar A. Perez Jr MD DPBOClinical Associate Professor
UP-PGH
Philippine Glaucoma Society
Monday, March 11, 13
Intro
• Alphabet Soup
• OHTS
• CIGTS
• TVT
• EMGT
• CNTGS
• AGIS
Monday, March 11, 13
“Doctor, why do we need to put those expensive eye drops for glaucoma?”
Monday, March 11, 13
OHTS
• Ocular Hypertension Study
- Aim: To determine if glaucoma drops delays or prevents glaucoma in ocular hypertensives
Monday, March 11, 13
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, 2002
Monday, March 11, 13
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 regimen
Monday, March 11, 13
OHTS Ocular Hypertension Study
• KEY FINDINGS
- First to demonstrate that lowering IOP delays/prevents glaucoma
- Identified risk factors in developing POAG
Monday, March 11, 13
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
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 groups
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OHTS Ocular Hypertension Study
• Lessons for Clinicians
- Take risk categories into account
- Consider observation before treatment in some patients
Monday, March 11, 13
OHTS Ocular Hypertension Study
• Lessons for Clinicians
- Treat those with:
‣ older age
‣ high cup to disk ratio
‣ high PSD in AVFs
‣ thin corneas
Monday, March 11, 13
“Doctor, I just learned I have glaucoma, which is better - drops or surgery?”
Monday, March 11, 13
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, 1999
Monday, March 11, 13
CIGTS
• Collaborative Initial Glaucoma Treatment Study
- 607 patients
- 5-9 years of follow-up
- Main Outcome Measure: AVFs
Monday, March 11, 13
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
- trabeculectomy
Monday, March 11, 13
CIGTS Collaborative Initial Glaucoma Treatment Study
• KEY FINDINGS
- Aggressive IOP targets yield results
- Quality of Life measured
Monday, March 11, 13
CIGTS Collaborative Initial Glaucoma Treatment Study
• Aggressive IOP targets yield results
- 35% reduction from medication
- 48% reduction from surgery
Monday, March 11, 13
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 few
Monday, March 11, 13
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 field
Monday, March 11, 13
“Doctor, I stopped my glaucoma medications, what will happen to my eyes?”
Monday, March 11, 13
EMGT Early Manifest Glaucoma Trial
• Treat IOP early, follow progress closely
Arch Ophthalmol 120: 1268-1279, 2002.
Monday, March 11, 13
EMGT
• Early Manifest Glaucoma Trial
- 255 patients
- 7 to 11 years of follow-up
- Main Outcome Measures: AVFs and optic disc photos
Monday, March 11, 13
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 appeared
Monday, March 11, 13
EMGT Early Manifest Glaucoma Trial
• KEY FINDINGS
- Treatment effect validated
- Every 1 mmHg reduction matters
- Disease progression is variable
- Mean IOP is vital
Monday, March 11, 13
EMGT Early Manifest Glaucoma Trial
• Lessons for clinicians
- Follow progression closely; reset target as needed
- Exfoliation as a risk factor
- Strive for the lower IOP
Monday, March 11, 13
EMGT Early Manifest Glaucoma Trial
• Lessons for clinicians
- Aggressive treatment if:
‣ pseudoexfoliation
‣ bilateral disease
‣ older patient
‣ higher IOP
‣ worse mean deviation
‣ disc hemorrhage
Monday, March 11, 13
“Doctor, why do I have glaucoma if my pressure is 20 mmHg?”
Monday, March 11, 13
CNTGS Collaborative Normal-Tension Glaucoma Study
• IOP reduction important even for normotensives
Curr Opin Ophthalmol. 2003;14(2):86-90.
Monday, March 11, 13
CNTGS
• Collaborative Normal-Tension Glaucoma Study
- 260 patients
- > 5 years of follow up
- Main Outcome Measures: AVF
Monday, March 11, 13
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 combination
Monday, March 11, 13
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 years
Monday, March 11, 13
CNTGS Collaborative Normal-Tension Glaucoma Study
• Lessons for Clinicians
- Distinguish between progressive and non-progressive disease
- Surgery may not be necessary
Monday, March 11, 13
CNTGS Collaborative Normal-Tension Glaucoma Study
• Lessons for Clinicians
- Aggressive treatment if:
- female patient
- presence of migraine
- disc hemorrhages
Monday, March 11, 13
“Doctor, which treatment is better for my glaucoma - trabeculectomy or laser?”
Monday, March 11, 13
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
AGIS
• Advanced Glaucoma Interventional Study
- 591 patients
- 8-11 years of follow up
- Main Outcome Measures: sustained decrease of visual field and visual acuity
Monday, March 11, 13
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
AGIS Advanced Glaucoma Interventional Study
• KEY FINDINGS
- Reducing IOP slows visual field loss
- Many patients achieved stability
- Race affected outcomes
Monday, March 11, 13
AGIS Advanced Glaucoma Interventional Study
• Lessons for clinicians
- Take race into account when choosing therapy
- Blacks should have laser first
- Whites should have trabeculectomy first
Monday, March 11, 13
“Doctor, which surgery is better for my glaucoma - trabeculectomy or tube?”
Monday, March 11, 13
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
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
TVT Trabeculectomy vs Tube Study
• KEY FINDINGS
- Trab vs. shunt: no clear winner
- Complications and failure rates
Monday, March 11, 13
TVT Trabeculectomy vs Tube Study
• Lessons for Clinicians
- Put tubes in armamentarium
- Assess patient’s unique needs
Monday, March 11, 13
Recap
• Present glaucoma clinical practice guidelines have strong evidences
• Identification of risk factors, degree of disease and quality of life is key
• Customize treatment
Monday, March 11, 13
Thank you for your attention :)
Monday, March 11, 13