Transcript Diapositiva 1 - ASCRS/ASOA 2008

Clinical study of open angle glaucoma surgery
treatment trough deep slerectomy with
T-Flux NV implant: three years follow-up
Dr. Marco Rossi
Dr Michele Schmidt
Dr. Paolo Garimoldi
Dr. Alberto Cazzola
Dr. Paolo Giorgi
Busto Arsizio Hospital – Varese, Italy
ASCRS – Chicago 2008
None of the authors have
financial interests
in the products mentioned
ASCRS – Chicago 2008
Introduction
 Deep sclerectomy (DS) is one of the main types of nonpenetrating filtering surgery and is a well recognized
alternative to standard trabeculectomy
PURPOSE
 To evaluate efficacy and security of deep sclerectomy
with T-Flux NV implant in the intra-ocular pressure
control (IOP) in patients affected by open angle
glaucoma
ASCRS – Chicago 2008
Deep sclerectomy: advantages
Non-penetrating technique
Lower post-operative complications
Safer surgery in advanced glaucoma
Reduced risk of endophthalmitis
Predictable post-operative IOP
Faster recover of visual acuity
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Materials and Methods
 38 eyes of 33 patients: mean age 67±12, median 69, 16
men and 17 women
 Diagnosis: 38 primary open angle glaucoma
 Surgery: DS with non-absorbable T-Flux NV implant
inserted within the scleral bed during Deep Sclerectomy
 Three years follow-up
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Materials and Methods
 Follow-up:
 Pre-operative IOP:
 Mean ± DS 22.7±5.8
mmHg
 38 patients to 6 months
 Median: 23 mmHg
 27 patients to 24 months
 Number of medication:
 21 patients to 36 months
 36 patients to 12 months
 Mean ± DS: 2.5±1
 Median: 2
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T-Flux NV implant
 T-Flux NV is a nonabsortable implant,
inserted within the scleral bed during a
deep sclerectomy
 Clinical characteristics
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Early post-operative complications
Small hyphema
15,8%
Shallow anterior chamber
7,9%
Corneal edema
7,9%
Choroidal detachment
NO
Implant dislocation
NO
Cataract formation
NO
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Surgical results – T-Flux implant
 The use of OCT-SA VisanteTM Zeiss
is become an important instrument
for the understanding of
 Anatomic features of anterior
chamber and angle
 Glaucoma surgery: filtration, loss of
filtration and reasons of loss of
filtration
No filtration
Filtration
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Filtration
Clinical results
intraocular pressure - IOP
 Hypotony in the first days after surgery
 No flat anterior chamber
 Good control of intraocular pressure
 After 6 months the IOP remains stable
 Filtration failure at 24 months: 31%
In the first 6 months: 19%
 Inadequate opening of complex
Descemet’s membrane-trabecular meshwork
 Inadequate depth of deep sclerectomy
After the first 6 months: 12%
 Progressive scarring of deep sclerectomy
 Nd:YAG laser
selective trabeculoplasty: 21%
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Results
 Post-operative IOP mean±SD
 12 months (n°36): 15,8±3,3
int. conf. inf. 95%: 14,5
int. conf. sup. 95%: 17
 18 months (n°34): 15.6±4
int. conf. inf. 95%: 13,9
int. conf. sup. 95%: 17,2
 24 months (n°27): 15,2±3,8
int. conf. inf. 95%: 13,6
int. conf. sup. 95%: 16,8
 N° of medication mean±SD
 12 months (n°36): 0,6±0,9
 18 months (n°34): 0,6±0,9
 24 months (n°27): 1±1,3
 36 months (n°21):1,2±1,7
 36 months (n° 21): 15,8±4,1
int. conf. inf. 95%: 13,8
int. conf. sup. 95%: 17,1
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Results: DS vs Trabeculectomy
 Complete success rate (IOP < 21 mmHg without medication):
DS+T-Flux
Trabeculectomy
 12 months: 66%
12 months:65%
 24 months: 57%
24 months:53%
P>0,5 not significant
 Qualified success rate
(PIO < 21 mmHg with or without medication)
DS+T-Flux
Trabeculectomy
 12 months: 94%
12 months:93%
 24 months: 93%
24 months:82%
P>0,5 not significant
ASCRS – Chicago 2008
Conclusions
Deep Sclerectomy is a safe and effective
surgery
Less number of post-operative complications
DS provides a good control of IOP in open angle
glaucoma
In our experience DS with implant seems to
provide a better control of IOP in long-term
follow-up, compared with standard
trabeculectomy
ASCRS – Chicago 2008
Limits of DS
Not possible in angle-closure glaucoma (?)
More complex surgery
Longer surgery, especially during the learning
curve
More expensive surgery
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Thank you
Dr. Michele Schmidt
Dr. Marco Rossi
ASCRS – Chicago 2008