A prospective randomised trial of viscocanalostomy with and without implantation of a reticulated hyaluronic acid implant (SKGEL) in open angle glaucoma

Abstract

Aim: To prospectively assess the efficacy and complications of viscocanalostomy with a reticulated hyaluronic acid implant (VSRHAI) versus standard viscocanalostomy in patients with medically uncontrolled open angle glaucoma. Methods: A consecutive series of 40 patients (40 eyes) with uncontrolled open angle glaucoma underwent non-penetrating antiglaucomatous surgery. After the excision of the deep scleral flap they were randomly assigned to either a standard viscocanalostomy or additional implantation of a reticulated hyaluronic acid implant. Follow up visits were over a period of 12 months after surgery. Results: The mean preoperative intraocular pressure (IOP) was 26.5 (SD 6.1) mm Hg for all patients enrolled. The mean IOP was 8.1 (SD 5.6) mm Hg 1 day after surgery for the viscocanalostomy group (p<0.001) and 12.0 (SD 5.2) mm Hg for the VSRHAI group (p<0.001). The postoperative IOP difference between the two groups was statistically significant (p = 0.03). The success rate, defined as an IOP lower than 22 mm Hg without medication, was 40% in both groups at 12 months postoperatively (p = 0.90). The number of postoperative complications was equally low for both groups. Conclusions: Both surgical procedures, viscocanalostomy and VSRHAI, provide comparable success rates over a 1 year follow up period. The specific intraoperative and postoperative complications of non-penetrating surgery were seen in our series, although the overall rate of postoperative complications proved equally low for both techniques.