1. 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

2. None of the authors have financial interests in the products mentioned
ASCRS – Chicago 2008

3. 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

4. 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
ASCRS – Chicago 2008

5. 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
ASCRS – Chicago 2008

6. Materials and Methods Follow-up: Pre-operative IOP:
38 patients to 6 months
36 patients to 12 months
27 patients to 24 months
21 patients to 36 months
Pre-operative IOP:
Mean ± DS 22.7±5.8 mmHg
Median: 23 mmHg
Number of medication:
Mean ± DS: 2.5±1
Median: 2
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7. 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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8. 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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9. 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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10. 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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11. Results Post-operative IOP mean±SD int. conf. inf. 95%: 14,5
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
36 months (n° 21): 15,8±4,1
int. conf. inf. 95%: 13,8
int. 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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12. 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)
12 months: 94% 12 months:93%
24 months: 93% 24 months:82%
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13. 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
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14. 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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15. Dr. Michele Schmidt Dr. Marco Rossi
Thank you
Dr. Michele Schmidt
Dr. Marco Rossi
ASCRS – Chicago 2008