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M. Papadia, F. De Feo, M. Mete, G. Bricola, C. E. Traverso; Long-Term Efficacy and Safety of a Stainless Steel Glaucoma Drainage Device Implanted Under Conjunctiva. Invest. Ophthalmol. Vis. Sci. 2007;48(13):820.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate long term efficacy and safety of a stainless steel miniature glaucoma drainage device (Ex-PRESSTM) implanted under conjunctiva, alone or combined with phacoemulsification.
Clinical, prospective, single treatment arm, non randomized, non masked study. The device was implanted just behind the limbus in 21 eyes of 20 patients (17 POAG and 3 PEC). In 15 patients (13 POAG and 2 PEC) the contemporary presence of a clinical relevant cataract required a procedure combined with phacoemulsification cataract extraction. The mean age was 77.7 +/- 7.4. Primary outcome: IOP change. Secondary outcomes: side effects and VA changes.
Efficacy and safety were evaluated on the entire sample (n=21) with a mean follow-up (F.U.) of 5 years (min. 2 years in 1 patient who died during follow up). Efficacy: preoperative IOP was 25.86 +/- 8.81 mmHg; at last follow-up the IOP was 17.19 +/- 7.16 mmHg (33.53% reduction). The success rate with IOP ≤ 18 mmHg at last visit with or without medications was 61.9% (13/21) and with IOP ≤ 18 mmHg without medications was 52.4% (11/21). The Kaplan Meyer cumulative proportion of success (IOP≤18 mmHg ) at 4 years was 51%. Two patients (9.5%) were treated topically at their last visit, with 1 medication. The difference between preoperative and last F.U. IOP rated with t-test was statistically significant (p<0.001). Complications: Early postoperative complications were clinically mild and included: postoperative IOP < 5 mmHg: 8 cases (38.1%) at 1 day, 4 cases (19%) at 1 week. Two conjunctival erosion were reported: in one case the implant was replaced; in one case scleral patch was positioned to cover the external plate of the device. Bleb needling, with or without 5FU injection, was used in 10 cases (47.6%) during follow-up.
Our data support the long-term efficacy and safety of the implantation of this device under conjunctiva. The rate of conjunctival erosion is low and is only due to a malposition of the device.
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