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Paul Palmberg, Juan Batlle, Rachel Alburquerque, Adalgisa Corona-Peralta, Isabelle Riss, Richard Parrish, Esdras Arrieta, Jean-Marie Parel; A Novel Minimally Invasive Drainage Implant (the MIDI-Arrow): One-Two Year Follow Up. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4491.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the safety and IOP lowering efficacy of a novel micro-lumen glaucoma drainage device used with MMC application and placed under a conjunctival flap.
Single site, single surgeon (JB) prospective single arm study in 23 eyes of 23 mixed-race adult subjects with POAG. 9 eyes underwent combined procedures and 14 had implantation alone. All eyes received an intraoperative wide application under the subconjunctival flap of 0.4 mg/ml MMC for 3 minutes (technique of Khaw). Subjects were seen at 1 day, 1 week, 1, 3, 6, 9, 12 and 24 months.
The mean IOP fell from a baseline of 24.0 +/- 5.4 mm Hg to 10.5 +/- 2.8 at 12 months (range 6-18, N=23) and to 10.2 +/- 2.0 at 2 years (N=10). Glaucoma meds fell from an average of 2.2 +/-1.0 to 0.3 at 12 months. Complete success, defined as an IOP >5 and <21, and a greater than 20% reduction in IOP without medical therapy, was 91%, and modified success (with medication) was 96% at one year. One subject required bleb needling at 90 days, and was at 10 mm Hg off meds at 2 years. 21 of 23 subjects had a wide, low profile ischemic bleb at 1 year. Complications included 2 subjects with transient shallow anterior chamber, 2 (combined cases) with transient choroidal detachment, 2 with transient hypotony after day one, none with chronic hypotony or maculopathy. The mean HVF MD was -15.6 +/- 13.3 at baseline and -15.5 +/- 13.3 at 1 year. There was no change in mean ETDRS Va at one year. No tube exposure, migration, or blockage, and no bleb infection was encountered.
The MIDI-arrow replaces a scleral flap with an 8.5 mm small internal diameter (62 u) flexible tube inplanted through a 3 mm needle track. The implant is made of the biocompatible material SIBS, poly(styrene-block-isobutylene-block-styrene). At 2 ul / min flow, the tube has a trans-scleral pressure drop of 5 mm Hg, avoiding hypotony problems. We believe that the success is attributable to minimal inflammation associated with only a needle track entry. The needle track which starts 3 mm posterior to the limbus (technique of Felix Gil) and small size of the tube appear to obviate the need for a patch graft to protect the tube as the lid margin does not rub over that location. The operation appears to require only rare post-operative intervention. An FDA trial of this device should begin soon.
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