June 2013
Volume 54, Issue 15
ARVO Annual Meeting Abstract  |   June 2013
A Novel Minimally Invasive Drainage Implant (the MIDI-Arrow): One-Two Year Follow Up
Author Affiliations & Notes
  • Paul Palmberg
    Biophysics (Ophthalmology), University of Miami, Miami, FL
  • Juan Batlle
    Centro Laser, Santo Domingo, Dominican Republic
  • Rachel Alburquerque
    Centro Laser, Santo Domingo, Dominican Republic
  • Adalgisa Corona-Peralta
    Centro Laser, Santo Domingo, Dominican Republic
  • Isabelle Riss
    Pole Ophtalmologogique, Clinique Mutualiste, Pessac, France
  • Richard Parrish
    Biophysics (Ophthalmology), University of Miami, Miami, FL
  • Esdras Arrieta
    Ophthalmology, University of Miami, Miami, FL
  • Jean-Marie Parel
    Ophthalmology, University of Miami, Miami, FL
  • Footnotes
    Commercial Relationships Paul Palmberg, AqueSys (C), Innovia (C), Aurolab (unpaid) (C), Aeon (DSMB) (R); Juan Batlle, Innovia LLC (C), Innovia LLC (F), OptiMedica Corporation (C), OptiMedica Corporation (F), PPI LLC (P), AqueSys (C), AqueSys (F), Reflow Biomedical Technologies (I), STAAR Surgical Co. (C), Emmetrope Ophthalmics, LLC (C), Croma (C); Rachel Alburquerque, Innovia LLC (C), Innovia LLC (F), AqueSys (C), AqueSys (F); Adalgisa Corona-Peralta, None; Isabelle Riss, None; Richard Parrish, AqueSys, Inc (C), Aerie Pharmaceuticals, Inc (C), Bausch + Lomb (C), Glaukos Corporation (C), InnFocus, Inc (C), Innolene LLC (R), Merck & Co, Inc (C), Vitalspring Technologies, Inc (I), Alimera Sciences, Inc (C); Esdras Arrieta, None; Jean-Marie Parel, CROMA (F), InnFocus (F), Abeamed (F), University of Miami (P)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 4491. doi:
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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)

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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.

Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 465 clinical (human) or epidemiologic studies: systems/equipment/techniques • 765 wound healing  

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