ascrs – chicago 2008 clinical study of open angle glaucoma
TRANSCRIPT
ASCRS – Chicago 2008
Clinical study of open angle glaucoma surgery treatment trough deep slerectomy with T-Flux NV implant: three years follow-up
Dr. Marco RossiDr Michele SchmidtDr. Paolo GarimoldiDr. Alberto CazzolaDr. 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 non-penetrating 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 techniqueLower post-operative complicationsSafer surgery in advanced glaucomaReduced risk of endophthalmitisPredictable post-operative IOPFaster recover of visual acuity
ASCRS – Chicago 2008
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
Pre-operative IOP: Mean ± DS 22.7±5.8
mmHg
Median: 23 mmHg
Number of medication: Mean ± DS: 2.5±1
Median: 2
Follow-up: 38 patients to 6 months
36 patients to 12 months
27 patients to 24 months
21 patients to 36 months
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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 Filtration
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Clinical resultsintraocular 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±3,3int. conf. inf. 95%: 14,5int. conf. sup. 95%: 17
18 months (n°34): 15.6±4int. conf. inf. 95%: 13,9int. conf. sup. 95%: 17,2
24 months (n°27): 15,2±3,8int. conf. inf. 95%: 13,6int. conf. sup. 95%: 16,8
36 months (n° 21): 15,8±4,1int. conf. inf. 95%: 13,8int. conf. sup. 95%: 17,1
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
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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 complicationsDS provides a good control of IOP in open angle
glaucomaIn our experience DS with implant seems to
provide a better control of IOP in long-term follow-up, compared with standard trabeculectomy
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Limits of DS
Not possible in angle-closure glaucoma (?)
More complex surgery
Longer surgery, especially during the learning
curve
More expensive surgery
ASCRS – Chicago 2008
Thank you
Dr. Michele Schmidt
Dr. Marco Rossi