Canaloplasty versus non-penetrating deep sclerectomy - a prospective, randomised study of the safety and efficacy of combined cataract and glaucoma surgery; 12-month follow-up.

PURPOSE

To compare outcomes of phaco-canaloplasty (PC) and phaco-non-penetrating deep sclerectomy (PDS) with a viscoelastic compound.

METHODS

This study included 29 eyes after PC and 30 after PDS. Indications were uncontrolled primary open-angle glaucoma (POAG) and a cataract. Corrected distance visual acuity (CDVA), intraocular pressure (IOP), and number of medications were evaluated. Follow-up examinations were performed on days 1 and 7, and after 1, 3, 6, and 12 months. Complete and qualified success was an IOP ≤ 18 mmHg.

RESULTS

At the 12-month follow-up, mean IOP decreased in the PC group from 19.0 ±6.9 mmHg to 12.6 ±2.7 mmHg, and in the PDS group, from 19.1 ±5.8 mmHg to 14.3 ±3.5 mmHg (P < 0.05). Both groups preoperatively and at 12 months showed no significant differences in IOP (P > 0.05). There was no statistically significant difference between the number of medications used (P > 0.05). Complete and qualified success rates for both groups were 79.0 % and 76.9 % (P = 0.701). The most frequent postoperative PC complication was hyphema (58.0 %); for PDS, bleb fibrosis was most frequent (26.7 %). No PC patients required postoperative management. PDS patients required postoperative interventions 58.7 % of the time, including a 5-fluorouracil (5-FU) injection (58.7 %), suture lysis (48.3 %), and needling (27.6 %).

CONCLUSIONS

Both PC and PDS lead to an effective decrease in IOP on a short-term follow-up basis and demonstrate similar efficacy and safety profiles. PDS patients required additional procedures including 5-FU injections, suture lysis, or needling. PC patients required no additional procedures.