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H.-L. Chen, X. Li, F. Yuan, W. Hsu; Clinical Experience With Biodegradable 3D-Porous Collagen-glycosaminoglycan Scaffold (OculusGenTM) for Treatment of Refractory Glaucoma. Invest. Ophthalmol. Vis. Sci. 2007;48(13):826.
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Based on experience learned from earlier animal study, we describe a short-term pilot study that evaluates the safety and efficacy of trabeculectomy with implantation of OculusGen in refractory glaucoma patients. OculusGen, by its characteristics, improves the regenerating tissue-remodeling and reduces scar formation by guiding fibroblast to grow through the matrix pores randomly.
In this multi-center, prospective and non-randomized study, 59 patients (M:25, F:34, age: 57.1 ± 12.4 yrs ) underwent trabeculectomy with new device in one eye for refractory glaucoma, which is defined as having previously failed medical, laser or surgical treatment, or some combination thereof. The OculusGen was implanted on the top of the scleral flap at the limbus before closing the conjunctival wound during trabeculectomy operations. Intraocular pressure (IOP), number of medications and complication were assessed before and after surgery.
The mean preoperative IOP was 38.7 ± 7.5 mmHg with 2.1 ± 0.9 antiglaucoma medications. Postoperatively, the mean IOP at last follow up (9 months) for all eyes was 16.1 ±3.2 mmHg (58.3% reduction, p < 0.05) with 0.3 ±0.2 antiglaucoma medications. There were no significant intra-operative complications in any patients. Post-operative complications including transient shallow anterior chamber, hyphema, choroidal detachment and hypotony, no endophthalmitis occurred in any patients.
The preliminary results of this study indicate that the OculusGen implantation in trabeculectomy represents a new, safe, simple and effective therapeutic approach for treating refractory glaucoma. Normalization of subconjunctival wound healing by tissue engineering is applied to traditional filtering surgery, bringing a novel approach to anti-scarring. A larger-scale study with a longer follow-up period is required to confirm these observation.The
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