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

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 foll

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  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. 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

  7. 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

  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 ASCRS – Chicago 2008

  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 Filtration No filtration Filtration ASCRS – Chicago 2008

  10. 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

  11. 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

  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) DS+T-Flux Trabeculectomy • 12 months: 94% 12 months:93% • 24 months: 93% 24 months:82% P>0,5 not significant ASCRS – Chicago 2008

  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 ASCRS – Chicago 2008

  14. 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

  15. Thank you Dr. Michele Schmidt Dr. Marco Rossi ASCRS – Chicago 2008

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