Abstract
This study evaluated the early outcomes of the hypotensive efficacy and safety profile of ab externo phaco-canaloplasty versus first-generation iStent bypass implantation combined with phacoemulsification in patients with primary open-angle glaucoma (POAG). In total, 82 patients with POAG comprising 92 eyes were divided into phaco-canaloplasty (Group PC, (n = 47) or iStent combined with phacoemulsification (Group PiS, n = 45) groups. Primary outcome measures were intraocular pressure (IOP) reduction and number of glaucoma medications. Secondary outcome measures were best-corrected visual acuity (BCVA), endothelial cell density (EECD), changes in anterior chamber depth (ACD), and complication rate. The follow-up period was approximately 6 months. Preoperative IOPs were 17.30 (15.00; 19.85) mmHg and 17.50 (15.10; 20.90) mmHg in the PC and PiS groups, respectively (p = 0.876). At the end of the follow-up, IOP decreased to 15.00 (13.00; 16.00) mmHg and 15.00 (14.00; 17.00) mmHg in the PC and PiS groups, respectively (p = 0.438). Medication usage decreased from 2.08 to 0.12 and 1.40 to 0.04 in PC and PiS eyes, respectively. Most patients in both groups were medication-free at 6 months follow-up. After 6 months of observation, EECD in PC and PiS groups decreased from 2309.50 (2032.00; 2533.00) to 1966.50 (1262.00; 2353.50) and 2160.00 (1958.50; 2372.50), to1231.00 (1089.00; 2050.00), respectively (p = 0.037). Pre-surgery BCVA was 0.80 (0.50; 1.00) and 0.60 (0.40; 1.00) in PC and PiS eyes, respectively (p = 0.456). Follow-up BCVA was 0.95 (0.60; 1.00) for PC and 1.00 (1.00; 1.00) for PiS. Hyphema and corneal oedema were noted on the first day post-surgery in both groups. Subsequent complications included a transient increase in IOP in the PC group. Phaco-canaloplasty and iStent bypass implantation combined with phacoemulsification significantly lowered IOP and decreased medication burden. All eyes in both groups maintained or exhibited improved BCVA relative to baseline. Both surgeries had low postoperative complication rates and exhibited comparable safety profiles over 6-month follow-up in patients with POAG.