April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Injectable Reticulated Hyaluronic Acid Implant For Deep Sclerectomy With Mitomycin C: A Case Series
Author Affiliations & Notes
  • Paolo Bettin
    Ophthalmology, Scientific Institute San Raffaele, Milano, Italy
  • Marina Fiori
    Ophthalmology, Scientific Institute San Raffaele, Milano, Italy
  • Carlo Ciampi
    Ophthalmology, Scientific Institute San Raffaele, Milano, Italy
  • Stefania Mazzarella
    Ophthalmology, Scientific Institute San Raffaele, Milano, Italy
  • Francesco Bandello
    Ophthalmology, Scientific Institute San Raffaele, Milano, Italy
  • Footnotes
    Commercial Relationships  Paolo Bettin, None; Marina Fiori, None; Carlo Ciampi, None; Stefania Mazzarella, None; Francesco Bandello, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 632. doi:
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      Paolo Bettin, Marina Fiori, Carlo Ciampi, Stefania Mazzarella, Francesco Bandello; Injectable Reticulated Hyaluronic Acid Implant For Deep Sclerectomy With Mitomycin C: A Case Series. Invest. Ophthalmol. Vis. Sci. 2011;52(14):632.

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Abstract

Purpose: : to assess safety and efficacy of mitomycin C (MMC) deep sclerectomy (DS) with a new injectable reticulated hyaluronic acid implant (HealaflowTM ) in open-angle glaucoma (OAG).

Methods: : we reviewed all MMC-DSs performed in our Center using HealaflowTM as a space-maintaining device. All procedures were done by the same surgeon (PB) in a standard fashion: fornix-based conjunctival dissection, 5x5 mm square half-thickness outer flap, trapezoidal inner flap, 2-minute 0.3 mg/ml MMC application, creation of a 3-mm-wide descemetic window, inner flap excision, outer flap closure with 4 10-0 nylon stitches, HealaflowTM injection under the flap, conjunctival sealing and bleb filling with HealaflowTM. Variables studied included IOP, BCVA, number of antiglaucoma medications, need for YAG goniopuncture and complications.

Results: : 40 eyes (35 patients, age 57.3±14.6* years) were studied. Preoperative diagnoses included 25 primary OAG, 4 pseudoexfoliative, 4 pigmentary, 3 uveitic, 2 normal-tension and 2 other OAGs. There were no intraoperative complications except for 1 uneventful Descemet's membrane microperforation and 1 transient IOP rise due to blood under the flap. IOP dropped from initial 26.5±7.3* mmHg on 3.7±0.9* medications to 11.6±3.2* mmHg (p=0.0000) at the end of the follow-up (10.4±6.2* months, range 1-26). Presently, 2 eyes need 1 medication to achieve target IOP and 3 eyes failed, requiring repeat filtering surgery at 3, 6 and 9 months. Initial and final BCVAs were 0.73±0.32* and 0.75±0.34* (n.s.). At 12 months, absolute (unmedicated) and qualified (with or without medication) success rates (Kaplan-Meier analysis, IOP 6-21 mmHg inclusive) were 81% and 89%; absolute "low-teen" success rate (IOP 6-16 mmHg inclusive) was 78%. As for postoperative adverse events, 1 eye required a compression suture of a high nasal bleb causing a dellen at 1 month, 1 eye showed a partial iris apposition to an intact descemetic window and had to start a monotherapy on month 11 and 2 eyes needed 5-fluoruracil injections. 19 eyes underwent YAG goniopuncture (after 3.7±4.2* months) following which 1 eye had a choroidal detachment (spontaneously healed in 1 month) and 5 eyes developed an iris plug at the puncture site: 4 were resolved by iris repositioning, YAG iridotomy and argon laser iridoplasty, whereas 1 required a surgical iridectomy.*Mean±SD

Conclusions: : MMC deep sclerectomy with injectable reticulated hyaluronic acid implant (HealaflowTM ) is safe and effective. Over time, approximately half of the operated eyes need YAG goniopuncture which can cause critical complications.

Keywords: clinical (human) or epidemiologic studies: systems/equipment/techniques • clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 
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