May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Long Term Efficacy and Safety of a Stainless Steel Glaucoma Drainage Device Implanted Under a Scleral Flap
Author Affiliations & Notes
  • R. Scotto
    Ophthalology, Di.N.O.G. University of Genoa, Genoa, Italy
  • F. De Feo
    Ophthalology, Di.N.O.G. University of Genoa, Genoa, Italy
  • A. Bagnis
    Ophthalology, Di.N.O.G. University of Genoa, Genoa, Italy
  • C. E. Traverso
    Ophthalology, Di.N.O.G. University of Genoa, Genoa, Italy
  • Footnotes
    Commercial Relationships  R. Scotto, None; F. De Feo, None; A. Bagnis, None; C.E. Traverso, Optonol LTD, F.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 4188. doi:https://doi.org/
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      R. Scotto, F. De Feo, A. Bagnis, C. E. Traverso; Long Term Efficacy and Safety of a Stainless Steel Glaucoma Drainage Device Implanted Under a Scleral Flap. Invest. Ophthalmol. Vis. Sci. 2008;49(13):4188. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To evaluate the efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESSTM X200) implanted under a scleral flap for the surgical treatment of primary open-angle glaucoma (POAG).

Methods: : In this single-centre study the Ex-PRESSTM device was implanted at the limbus under a scleral flap in 37 eyes of 35 patients with POAG. Primary outcome: IOP change. Secondary outcomes: side effects and VA changes.

Results: : The efficacy and safety were evaluated on the full sample, with a minimum FU of 12 months (max 24, mean 18). Pre-operative IOP was 27.6±8.7 mmHg; at last follow-up IOP was 12.4±3.4 mmHg (55.1% reduction). The success rate (IOP < 18 mmHg at last visit without medications) was 94.6% (35/37). Early post-operative complications were clinically mild and included: post-operative IOP < 5 mmHg: 12 cases at 1 day, 8 cases at 1 week, 3 cases at 1 month, 1 case at 3 months; serous choroidal detachment: 9 cases, 3 spontaneusly resolved, while in 6 cases hypotony and flat chamber were treated with viscoelastic injection in the anterior chamber. At last follow-up 6 patients were treated with 2 IOP lowering medications. No sight-threatening consequences of surgery were observed. There were 8 cases (21.6%, n=37) of bleb needling, with or without 5FU.

Conclusions: : Our data support the efficacy and safety of the implantation of this device under a scleral flap (Flap-Ex-PRESS). The IOP reduction obtained was significant, long-standing and complications were minimal.

Keywords: intraocular pressure • wound healing 
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