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