Purpose: To evaluate the safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm canal, a new nonpenetrating surgical procedure (canaloplasty) to treat open-angle glaucoma (OAG), combined with clear corneal phacoemulsification and posterior chamber intraocular lens (IOL) implantation.
Setting: Multicenter surgical sites.
Methods: This international multicenter prospective study comprised adult patients with OAG having combined glaucoma and cataract surgery. Patients with qualifying treated preoperative intraocular pressure (IOP) of at least 21 mm Hg or higher and open angles were eligible. Evaluation was performed at baseline and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. Intraoperative and postoperative high-resolution ultrasound imaging was used to assess Schlemm canal and anterior segment angle morphology, including distension of the trabecular meshwork due to the tensioning suture.
Results: Data from 54 eyes that had combined glaucoma and cataract surgery performed by 11 surgeons at 9 study sites were analyzed for this interim analysis. The mean baseline IOP was 24.4 mm Hg+/-6.1 (SD) with a mean of 1.5+/-1.0 medications per eye. In all eyes, the mean postoperative IOP was 13.6+/-3.8 mm Hg at 1 month, 14.2+/-3.6 mm Hg at 3 months, 13.0+/-2.9 mm Hg at 6 months, and 13.7+/-4.4 mm Hg at 12 months. Medication use dropped to a mean of 0.2+/-0.4 per patient at 12 months. Surgical complications were reported in 5 eyes (9.3%) and included hyphema (n=3, 5.6%), Descemet tear (n=1, 1.9%), and iris prolapse (n=1, 1.9%). Transient IOP elevation of more than 30 mm Hg was observed in 4 eyes (7.3%) 1 day postoperatively.
Conclusion: Circumferential viscodilation and tensioning of Schlemm canal combined with clear corneal phacoemulsification and posterior chamber IOL implantation was a safe and effective procedure to reduce IOP in adult patients with OAG.