ascrs – chicago 2008 clinical study of open angle glaucoma

ASCRS – Chicago 2008

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

Dr. Marco RossiDr Michele SchmidtDr. Paolo GarimoldiDr. Alberto CazzolaDr. 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 techniqueLower post-operative complicationsSafer surgery in advanced glaucomaReduced risk of endophthalmitisPredictable post-operative IOPFaster recover of visual acuity

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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

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Materials and Methods

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

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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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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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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 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%

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Results Post-operative IOP mean±SD

12 months (n°36): 15,8±3,3int. conf. inf. 95%: 14,5int. conf. sup. 95%: 17

18 months (n°34): 15.6±4int. conf. inf. 95%: 13,9int. conf. sup. 95%: 17,2

24 months (n°27): 15,2±3,8int. conf. inf. 95%: 13,6int. conf. sup. 95%: 16,8

36 months (n° 21): 15,8±4,1int. conf. inf. 95%: 13,8int. 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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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

Deep Sclerectomy is a safe and effective surgery

Less number of post-operative complicationsDS provides a good control of IOP in open angle

glaucomaIn 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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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