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 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 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 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 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 ASCRS – Chicago 2008

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 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 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 ASCRS – Chicago 2008

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% ASCRS – Chicago 2008

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 ASCRS – Chicago 2008

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% 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 ASCRS – Chicago 2008

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