Safety and Efficacy of Collagen Matrix Implantation in Infantile Glaucoma

Abstract

Purpose To evaluate the preliminary results of biodegradable collagen matrix implant (Ologen) designed to improve outcome in patients with infantile glaucoma undergoing combined trabeculotomy and trabeculectomy. Methods A biodegradable collagen matrix (OculusGen) was placed in the subconjunctival space, partially over the scleral flap and the sclera in 20 eyes of 11 patients with infantile glaucoma who underwent combined trabeculotomy and trabeculectomy. Patients were examined preoperatively and on the first postoperative day with multiple postoperative follow-up visits within 12 months after surgery. Examination included measurements of intraocular pressure (IOP), corneal diameter, and axial length, bleb evaluation, and funduscopy. Ultrasound biomicroscopy of bleb (bleb presence, wall reflectivity, and scleral route visibility) was done at 1, 3, and 6 months and the last follow-up visit. Any complication was recorded. Data analysis was performed using paired-samples t test. Results Mean patient age was 5.7 ± 5.69 months. Mean duration of follow-up was 10.05 ± 1.15 months. Mean preoperative IOP was 25.9 ± 3.08 mm Hg with 1.75 ± 0.55 IOP-lowering medications and mean final postoperative IOP was 17.7 ± 3.51 mm Hg with 0.55 ± 0.69 IOP-lowering medications. Overall success at last follow-up was 80%. None of the patients experienced systemic or ocular complication related to OculusGen. By the 6th month, complete Ologen degradation was evident in all cases. Conclusions The short-term preliminary results of this study indicate that the combined trabeculotomy and trabeculectomy with Ologen implantation could potentially provide a safe and effective procedure in the infantile age group but longer duration of follow-up in larger number of patients is needed.