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Clinical study of open angle glaucoma surgery treatment trough deep slerectomy with T-Flux NV implant: three years foll PowerPoint Presentation
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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.

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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

introduction
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
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

materials and methods
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

materials and methods6
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

Materials and Methods

ASCRS – Chicago 2008

t flux nv implant
T-Flux NV implant
  • T-Flux NV is a nonabsortable implant, inserted within the scleral bed during a deep sclerectomy
  • Clinical characteristics

ASCRS – Chicago 2008

early post operative complications
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

ASCRS – Chicago 2008

surgical results t flux implant
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

Filtration

No filtration

Filtration

ASCRS – Chicago 2008

clinical results intraocular pressure iop
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%

ASCRS – Chicago 2008

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

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

Results

ASCRS – Chicago 2008

results ds vs trabeculectomy
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
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
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

Thank you

Dr. Michele Schmidt

Dr. Marco Rossi

ASCRS – Chicago 2008