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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 CRITERIA
5 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 complications
1. Elevated IOP
2. 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

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advanced glaucoma intervention study

  • 2. 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
  • 3. • 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
  • 5. 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?
  • 6. 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
  • 7. • Visual acuity, gonioscopy, and fundoscopy were each assessed 1X • visual field testing was 2X, and • IOP was assessed 3X at baseline.
  • 8.
  • 9. • 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.
  • 10.
  • 11.
  • 12.
  • 15. 1.SCORE 1 if 4 or >4 points depressed >12 db add +1
  • 16. 2.each hemifield (23 points) SCORE Cluster with depressed test sites 1 3-5 2 6-12 3 12-20 4 >20
  • 17. 3.THRESHOLD SCORE CRITERIA 5 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
  • 18. 4 So can consider 2 points One should be <12 db ADD +1
  • 19. Remember… The maximum possible score is 20 (2 for the nasal field and 9 for each hemifield).
  • 21.
  • 23. • 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
  • 24.
  • 27. • 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
  • 28.  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
  • 31. FAILED ALT + TRAB (vs) TRAB (119 EYES) (379 EYES) Data on bleb encapsualtion collecetd at dx,3m and 6m later
  • 32.
  • 34. BUT…. Encapsulation of bleb Males >> Females
  • 36. TYPE Type 1 cataract Type 2 cataract BCVA better than 6/15 Worse than 6/15
  • 37.
  • 39. • 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
  • 40. • 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.
  • 41. MOST IMPORTANT… IOP LESS FIELD PROGRESSION LESS
  • 43. ???
  • 44.
  • 45.
  • 46.  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 %
  • 50. 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
  • 51. • 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.
  • 53.
  • 54.
  • 55.
  • 56.
  • 57.
  • 58.
  • 60. 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 complications 1. Elevated IOP 2. marked inflammation
  • 62. 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??
  • 66. • 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%
  • 67.
  • 68.
  • 69. 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.

Editor's Notes

  1. Early failure occurs within 6 weeks after the first or second half of argon laser trabeculoplasty (ALT) or within 6 weeks after trabeculectomy. The occurrence of early failure is determined by the ophthalmologist member of, or an ophthalmologist consultant to, the Operations Committee according to guidelines specified in the manual of operations.
  2. 52 test locations for grading, 23 in each hemifield and 6 in the nasal field.
  3. Decrease of visual field (DVF) is an increase from baseline of at least 4 points on a glaucoma visual field decrease of visual acuity (DVA) is a decrease from baseline of atleast 15 letters (3 lines), decrease of vision (Dv) is the occurrence of either DVF or DVA.
  4. Black patients had a higher rate of failure with filtration surgery than did white patients. The reasons for this finding are likely multifactorial, but one important consideration Is that an antifibrotic agent was used in only 0.5% of primary filtering surgerie in the AGIS. Broadway et al obtained conjunctival biopsiesat the time of filtration surgery from 90 patients with glaucoma; 45 patients were black, and 45 were white. Conjunctiva from black patients was found to containa greater Number of macrophage and a smaller number Of both mast and goblet cells compared with that of white patients.There was a tendency for the conjunctiva from black patient to contain more fibroblasts.Agreaternumberofconjunctivalmacrophagesandpossiblyfibroblastsinblackpatientsmaypartiallyexplainthetendencyforalowersuccessratewithfiltration surgery in this group of patients.
  5. One report documented elevated levels of TGF-beta 2 in the aqueous of patients with pseudoexfoliation after ALT prior to undergoing trabeculectomy than without prior ALT therapy, and it found that the former were more prone to bleb scarring.
  6. Decrease of visual field (DVF) is an increase from baseline of at least 4 points on a glaucoma visual field decrease of visual acuity (DVA) is a decrease from baseline of atleast 15 letters (3 lines),
  7. Visual field and visual acuity improved after cataract surgery, with the amount of improvement greater in white than in black patients. In black and white patients, the worse the presurgical visual acuity, the greater the expected improvement in visual field
  8. Black patients had a significantly higher rate of failure, an IOP equal to or greater than 18 mm Hg, and a decline in visual field progression than white patients who underwent the TAT sequence. One of the disadvantages of the AGIS is the limited use of antifibrotic agents during trabeculectomy, particularly as a primary intervention. The extended use of these agents has been associated with better results in black patients and is largely the standard of care in our practice.
  9. In the TAT sequence, blacks were at greater risk than whites of IOP&amp;gt;18 mm Hg and of visual field loss. Black patients were at lower risk than white patients of failing initial ALT and at greater risk than white patients of failing initial trabeculectomy. In both treatment sequences, on average, the effort to control disease progression resulted in a greater number of medications prescribed for eyes of black than white patients (AGIS Report No. 9). 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.