advanced glaucoma intervention study
TRANSCRIPT
ADVANCED GLAUCOMA INTERVENTION STUDY
SIVATEJA CHALLA
INTRODUCTION• multicentric, prospective, randomized study
• on advanced primary open-angle glaucoma patients (POAG) that have failed initial medical treatment.
• 11 clinical centers in the United States
http://pub.emmes.com/study/agi/index.htm
• 789 eyes of 591 Patients
• April 1988 and November 1992
• Follow-up is projected to continue until march 2001
• Results published accordingly in 14 parts
AGIS 1
OBJECTIVES…•What is the clinical course and what are the outcomes after current therapies?•How effective in preserving vision are two sequences of surgical treatments, one starting with ALT and the other with trabeculectomy? •What are the early and late complication rates? •Can factors be identified that predict outcome with sufficient accuracy to help the ophthalmologist in planning treatment for a patient?
Inclusion and exclusion• Age 35-80 years• POAG• IOP >18 MM hg• Study eye is on MMT• Study eye is treatable with
either ALT or trabeculectomy.• able to cooperate with study
procedures and able to perform tests reliably
• signs consent form
• congenital anomaly of the AC or angle
• secondary glaucoma• kidney dialysis.• Eyes that have undergone
gonioplasty• Eyes with PDR or severe
NPDR.• field loss attributed to a
nonglaucoma condition.• pupil diameter of less than 2
mm
• Visual acuity, gonioscopy, and fundoscopy were each assessed 1X
• visual field testing was 2X, and
• IOP was assessed 3X at baseline.
• Failure was defined as an eye on MMT that met the study’s eligibility criteria for elevated IOP,Visual field defects, and optic disc rim deterioration
• IOP was measured 1 and 4 weeks after each operation, and visual acuity ,visual fields ,and IOP were assessed 3 and 6 months after enrollment and then biannually thereafter. Data collection closed March 31, 2001.
AGIS 2
SCORING 1 - 20
1.SCORE 1
if 4 or >4 points depressed >12 db add +1
2.each hemifield (23 points)SCORE Cluster with
depressed test sites
1 3-5
2 6-12
3 12-20
4 >20
3.THRESHOLD
SCORE CRITERIA5 If half or more defective locations
in a hemifield are depressed 28 dB or more
4 27-24
3 23-20
2 19-16
1 15-12
4
So can consider 2 points
One should be <12 db
ADD +1
Remember…
The maximum possible score is 20 (2 for the nasal field and 9 for each hemifield).
Reliability rating
AGIS 3
• examine the differences at baseline in demographic, medical, and ophthalmic characteristics between blacks and whites enrolled
• Age blacks younger to whites• Systemic HTN blacks > whites• VF defects severity blacks > whites• IOP similar in both groups• Blacks were more hyperopic and had relatively fewer
disk rim hemorrhages than whites.• Concluded that POAG occurs at more younger age in
blacks than whites and progression is also fast
But... DISC HGE
AGIS 4
• Average percent of eyes with decrease of visual field (APDVF)• average percent of eyes with decrease of visual acuity (APDVA), • average percent of eyes with decrease of vision (APDV)
Observed every six monthly till seven years
IOP reduction TAT >> ATT failure of the first intervention ATT>>TAT black patients VF, VA, and DV are less for the ATT
sequence than for the TAT sequence throughout the 7 years.
white patients, VF, VA, DV favors the ATT sequence but only for the first year, after which it favors the TAT sequence through the seventh year
A-T-T T-A-T
AGIS 5
FAILED ALT + TRAB (vs) TRAB (119 EYES) (379 EYES)
Data on bleb encapsualtion collecetd at dx,3m and 6m later
Stastistically not significant
BUT….Encapsulation of bleb Males >> Females
AGIS 6
TYPE Type 1 cataract
Type 2 cataract
BCVA better than 6/15 Worse than 6/15
AGIS 7
• 6m f/u for six yrs• Observations :• early average IOP > 17.5 mm Hg had significant
worsening of visual field progression compared with eyes that had an IOP < 14 mm Hg
• IOP < 18 100% TIMES – no change in VF progression• IOP <18 50% times – significant VF deterioration• Eyes with an IOP of > 17.5 mm higher prevalence of
diabetes• Black patients were more likely to have diabetes
compared with white patients.
MOST IMPORTANT…
IOP LESS FIELD PROGRESSION LESS
AGIS 8
???
After first trab whether next intervention done or not increases risk by 78%
After trab no post op complications cataract formation reduced by 47 %
After trab post op complications cataract formation increased by 104 %
So………
AGIS 9
A-T-T vs T-A-T
A-T-T
• Blacks were at lower risk than whites of failure of first intervention
T-A-T
• Blacks were at higher risk than whites of failure of the first intervention
In both treatment sequences, the average number of prescribed medications was greater for blacks than whites
• 30% of black patients eyes and 39% of white patients eyes underwent a second intervention in the ATT sequence
• 18% of black patients eyes and 13% of white patients eyes in the TAT sequence.
AGIS 10
AGIS 11
Pre intervention factors(asso c failure rate more)
ALT• younger age • higher IOP
TRAB• younger age • higher IOP • diabetes
Post intervention factors(asso c failure rate more)
• Postoperative complications1. Elevated IOP2. marked inflammation
AGIS 12
sustained decrease of visual field (SDVF)
• Better baseline visual field in both treatment sequences
• Male gender• worse baseline visual acuity
in the ATT sequence• diabetes in the TAT
sequence
sustained decrease of visual acuity (SDVA).
• Better baseline visual acuity• older age• less formal education
RISK FACTORS??
AGIS 13
A-T-T T-A-T
AGIS 14
• To determine the least worsening of a visual field (VF) and the least number of confirming tests needed to identify progression of glaucomatous VF defects.
• Patients with advanced glaucoma, a single confirmatory test 6 months after a VF worsening indicates with at least 72% probability a persistent defect
• Confirmatory tests is increased from 1 to 2, the percentage of eyes that show a persistent defect increases from 72% to 84%
TAKE HOME MESSAGE• Interaction between race and treatment
sequence• A relationship between IOP and VF stability• Visual function improved after cataract
surgery• More cataracts after trabeculectomy• Race differences in the progression of
advanced glaucoma.
THANK YOU