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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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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).
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.
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
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.
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