Safety and Efficacy of Three Modifications of Canaloplasty to Treat Open-Angle Glaucoma: 3-Year Outcomes.

ABSTRACT

BACKGROUND: This is a report of 3-year results of a prospective assessment of three modifications of canaloplasty (C) ab externo (ABeC), mini-canaloplasty (miniABeC), and ab interno (ABiC) performed concomitantly with cataract removal in subjects suffering from primary open-angle glaucoma (POAG). METHODS: Forty-eight individuals were randomized for one of the surgeries ABeC, miniABeC, or ABiC and cataract removal-16 eyes for each group. Follow-up examinations were carried out on the day of the surgery, on days 1 and 7, after 1, 3, 6 months, and at 1, 2, and 3 years. Complete and qualified success was an IOP ≤ 15 mmHg without or with antiglaucoma eye drops, respectively. The IOP reduction of 20% or more was considered an additional success criterion. RESULTS: Within three years the probability of qualified success was ABiC and miniABeC-94%, ABeC-100%, and of complete success ABiC-75%, miniABeC-100%. At the 3-year follow-up, the median IOP decreased from 22 to 15 mmHg in the ABeC group (p = 0.001), from 22 to 15 mmHg in the miniABeC group 15 (p < 0.001), and from 21 to 15 mmHg in the ABiC group (p = 0.001) compared to the post-washout stage. The IOP dropped by 20% or more without medications in 56.2% of patients post ABiC, 68.8% post miniABeC and 75% post ABeC. The median number of antiglaucoma medications dropped in all three groups; at the 3-year follow-up, only one patient following ABeC and four subjects following miniABeC required treatment. One patient required reoperation and further intensification of topical treatment-post miniABeC. The levels of IOP, CDVA, and success probability at the 36-month follow-up showed no significant difference for individual groups. CONCLUSIONS: ABeC, miniABeC, and ABiC have significant IOP-lowering potential in individuals diagnosed with POAG at a mild to moderate stage and no history of IOP ≥ 30 mmHg with a good safety profile.