Clinical study of open angle glaucoma surgery treatment

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Clinical study of open angle glaucoma surgery treatment trough deep slerectomy with T-Flux NV

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

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 nonpenetrating filtering

Introduction [ Deep sclerectomy (DS) is one of the main types of nonpenetrating 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 üNon-penetrating technique üLower post-operative complications üSafer surgery in advanced glaucoma üReduced

Deep sclerectomy: advantages üNon-penetrating technique üLower post-operative complications üSafer surgery in advanced glaucoma üReduced risk of endophthalmitis üPredictable post-operative IOP üFaster recover of visual acuity ASCRS – Chicago 2008

Materials and Methods [ 38 eyes of 33 patients: mean age 67± 12, median

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: þ Mean ± DS 22. 7±

Materials and Methods [ Follow-up: [ Pre-operative IOP: þ Mean ± DS 22. 7± 5. 8 mm. Hg þ 38 patients to 6 months þ Median: 23 mm. Hg þ 36 patients to 12 months [ Number of medication: þ 27 patients to 24 months þ Mean ± DS: 2. 5± 1 þ 21 patients to 36 months þ Median: 2 ASCRS – Chicago 2008

T-Flux NV implant [ T-Flux NV is a nonabsortable implant, inserted within the scleral

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%

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 Visante. TM Zeiss is

Surgical results – T-Flux implant [ The use of OCT-SA Visante. TM Zeiss is become an important instrument for the understanding of þ Anatomic features of anterior chamber and angle þ Glaucoma surgery: filtration, loss of filtration and reasons of loss of filtration No filtration Filtration ASCRS – Chicago 2008 Filtration

Clinical results intraocular pressure - IOP [ Hypotony in the first days after surgery

Clinical results intraocular pressure - IOP [ Hypotony in the first days after surgery þ No flat anterior chamber [ Good control of intraocular pressure þ After 6 months the IOP remains stable [ Filtration failure at 24 months: 31% In the first 6 months: 19% þ Inadequate opening of complex Descemet’s membrane-trabecular meshwork þ Inadequate depth of deep sclerectomy After the first 6 months: 12% þ Progressive scarring of deep sclerectomy [ Nd: YAG laser selective trabeculoplasty: 21% ASCRS – Chicago 2008

Results [ Post-operative IOP mean±SD þ 12 months (n° 36): 15, 8± 3, 3

Results [ Post-operative IOP mean±SD þ 12 months (n° 36): 15, 8± 3, 3 int. conf. inf. 95%: 14, 5 int. conf. sup. 95%: 17 þ 18 months (n° 34): 15. 6± 4 int. conf. inf. 95%: 13, 9 int. conf. sup. 95%: 17, 2 þ 24 months (n° 27): 15, 2± 3, 8 int. conf. inf. 95%: 13, 6 int. conf. sup. 95%: 16, 8 [ N° of medication mean±SD þ 12 months (n° 36): 0, 6± 0, 9 þ 18 months (n° 34): 0, 6± 0, 9 þ 24 months (n° 27): 1± 1, 3 þ 36 months (n° 21): 1, 2± 1, 7 þ 36 months (n° 21): 15, 8± 4, 1 int. conf. inf. 95%: 13, 8 int. conf. sup. 95%: 17, 1 ASCRS – Chicago 2008

Results: DS vs Trabeculectomy [ Complete success rate (IOP < 21 mm. Hg without

Results: DS vs Trabeculectomy [ Complete success rate (IOP < 21 mm. Hg without medication): DS+T-Flux Trabeculectomy þ 12 months: 66% 12 months: 65% þ 24 months: 57% 24 months: 53% P>0, 5 not significant [ Qualified success rate (PIO < 21 mm. Hg with or without medication) DS+T-Flux Trabeculectomy þ 12 months: 94% 12 months: 93% þ 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

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

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 ASCRS – Chicago 2008

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

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