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Paolo Bettin, Marina Fiori, Carlo Ciampi, Federico Di Matteo, Francesco Bandello; Mitomycin-C Deep Sclerectomy With Injectable Cross-Linked Hyaluronic Acid Implant: 3-Year Report Of An Ongoing Case Series. Invest. Ophthalmol. Vis. Sci. 2012;53(14):5940.
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to assess safety and efficacy of mitomycin-C (MMC) deep sclerectomy (DS) with injectable cross-linked hyaluronic acid implant (Healaflow™) as a space-maintaining device in open-angle glaucoma (OAG) eyes.
all eyes undergoing Healaflow™ MMC-DS in our Center are included in an ongoing observational case series. All surgeries are done by one of us (PB) with a standard technique: fornix-based conjunctival dissection, 5x5mm square half-scleral-thickness outer flap, trapezoidal deep flap deroofing Schlemm’s canal, 2-minute 0.3 mg/ml MMC application, cleavage of a 3mm-wide descemetic window allowing aqueous percolation (eventually enhanced by Schlemm’s canal wall stripping), inner flap excision, outer flap closure with 4 10-0 nylon sutures, Healaflow™ injection under the flap until it oozes from its margins, conjunctival sealing and bleb filling with Healaflow™. Variables studied are: IOP, BCVA, number of glaucoma medications, intra and postoperative complications.
presently, the series includes 55 eyes of 47 patients (age 56.4±14.2* years). Diagnoses were: 34 primary, 8 pigmentary, 4 pseudoexfoliative, 4 uveitic, 3 normal-tension and 2 other OAGs; 27 eyes were phakic. Intraoperatively, there were 2 uneventful Descemet microperforations [#17,42] and 1 choroidal exposure requiring 2 10-0 nylon sutures [#52].IOP dropped from 26.2±8.1*mmHg on 3.6±0.9* medications preoperatively to 11.3±3.7*mmHg (p=0.0000) at the end of follow-up (16.6±9.2* months, range 1-38): 1 eye needs 1 medication to achieve target IOP. 4 eyes [#8,11,30,16] failed, requiring repeat surgery at 3, 6, 9 and 22 months. Preoperative and final BCVAs were 0.76±0.31* and 0.76±0.29* (n.s.).At 1 and 2 years, success (Kaplan-Meier, unmedicated IOP 5-21mmHg inclusive) was 89% and 89%, while "low-teen" success (unmedicated IOP 5-16mmHg inclusive) was 85% and 77% respectively.Postoperative complications were: 1 transient IOP rise [#15] due to a clot under the flap, 1 dellen requiring compression suture of a nasal bleb [#21] and 1 partial iris apposition to descemetic window [#13].2 eyes [#13,16] had 5-fluoruracil injections and 2 [#18,29] had phacoemulsification at 10 and 16 months.27 eyes required YAG goniopuncture (at 6.1±7.3* months) after which 1 had a transient choroidal and 5 had an iris plug at puncture site: 4 were resolved by iris repositioning, laser iridotomy and iridoplasty, 1 required surgical iridectomy. Since 2010, we perform laser iridotomy and localized iridoplasty before minimally puncturing Descemet’s membrane: no iris incarceration occurred thereafter.*Mean±SD
MMC DS with Healaflow™ is safe and effective in OAG. Half of the cases need goniopuncture over time.
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