1. Trabeculectomy With or Without PI:
A Prospective Randomized Pilot Study
A Kaplan-Messas
Head of glaucoma service
Assaf Harofe Medical Center
Tsrifin, Israel

2. Trab. With or without PI?
Rationale
Our Study
Discussion
Conclusions

3. From Basal iridectomy (1857) to
guarded filtering surgery (1968)
NPDS
Short Shunts
PI as a part of glaucoma surgery?

4. Rationale for PI
To avoid Pupillary block (phakic, narrow)
To avoid Iris Incarceration in inner ostium.
But….Possible Complications of PI:
Hyphema , Iridodyalisis, Inflammation
rarely Post-operative glare,esthetic concern,
cutting of the haptic, loop incarceration

5. Rationale for avoiding PI
Enhancing safety: bleeding, shallowing of
the anterior chamber, and crystalline lens
damage.
Enhancing efficacy: disruption of the
blood- aqueous-barrier.
Topical anesthesia :Eliminating the most
painful portion of the surgery
( Shortens the surgery)

6. Study Design
Prospective trial, IRB approved
2 arms, randomized, unmasked
Endpoints:
Success rate
IOP reduction,
Per and post -operative complications

7. Patients and Methods
48 Eyes with medically uncontrolled OAG
Same surgeon
14 visits, Follow up to 12 months
OAG  Phaco-Trab (36) or Trab. (12)

8. Inclusion/Exclusion criteria
>18y
POAG, PXFG, PDG
Exclusion:
Secondary glaucoma, NVG.
Previous ophthalmic surgery (including cataract).
Glaucoma laser Tx in the last 6 months.
Occludable or closed angle.

9. Demographics
Charact
aristics
Age IOP PH-VA # of
Meds
CDR
PI 75.0
10.8
26.9
1.9
0.27
0.25
3.1
1.0
0.79
0.02
No PI 75.2
6.9
28.0
2.0
0.33
0.24
3.24
1.1
0.88
0.03
P-value 0.96 0.7 0.39 0.47 0.012

10. Technique
Fornix based
40% depth flap of 2mm x 2mm flap up to
descemet.
MMC 0.02% 1 minute (MSS)
Phaco-PCIOL (clear cornea temporal)
+/- PI
2-4 releasable 10-0 sutures on flap.
2 conjunctiva-cornea sutures.
No cycloplegia post-operativelly.

11. IOP reduction
IOP(mmHg) No PI PI p value
1 month 13.4  4.8 11.5  3.7 0.18
6 months 12.5  4.0 11.2  3.5 0.31
1 year 12.4  0.7 12.9  0.9 0.61

12. Need for Medication
to reach target IOP
No PI PI p value
1 month 0.1  0.09 0.08  0.1 0.4
6 months 0.34  0.1 0.2  0.1 0.7
1 year 0.43  0.1 0.46  0.2 0.9

13. Success Rate
IOP < 18 mmHg without (complete)
or with medication (qualified) : No statistically
significant difference
PI group: 80 and 91 %
No PI group: 82 and 95%
filtering bleb appearance (vascularization, size, elevation) presence of
peripheral anterior synechia at the location of the inner ostium (per
gonioscopy) did not differ statistically between the 2 groups.

14. Safety
no PI group PI group
Shallow AC
IOP<6
0
3
2 (p=0.23, fischer
exact test)
1
Hyphema 1 2 (p=0.75, Chi
Square)
Flare>0.5
Cells >0.5
2 7 (p=0.14, Chi
Square)
CME 1 0
Iris Incarceration 0 1
No Blebitis or endophtalmitis in this series

15. Iris obstruction of the ostium
1 case in no PI group
D14 after 1 RS removal + massage
IOP=24mmHg
Intervention: Iris ironing with spatula in
OR/ topical
IOP post 12 mmHg

16. Significance
Anova with repeated measures
• Effect of time was found significant (p=0.000)
• Interaction between time and group significant
(p=0.000)
Each group behaves differently/ time

17. Published Studies
Shingleton, Chaudry (JCRS june 2002)
126 eyes Retrospective
No difference between PI and no PI for VA, IOP,
complications.
No ostium obstruction by the iris
Manners, Mireskandi
25 phacotrabeculectomy no PI: IOP drops from
23.4 to 15.9 and 15.4 at 6 and 12M (10% on
meds)

18. Conclusion
Trabeculectomy no PI maybe a different
procedure, alternative.
For OAG in phaco-trab or in pseudophakic
eyes (topical, Releasable Sutures)
Not for trabeculectomy in phakic eyes?
Long term remains to be studied.