Two-Year Outcomes of Combined Phacoemulsification and Ab Interno Tanito Microhook Trabeculotomy in Open-Angle Glaucoma: A Prospective Randomized Trial.

PURPOSE

To evaluate the 24-month safety and efficacy of phacoemulsification combined with ab interno Tanito microhook trabeculotomy (microLOT) compared with phacoemulsification alone in patients with open-angle glaucoma (OAG) and cataract.

DESIGN

Prospective, randomized, interventional clinical trial.

PARTICIPANTS

Patients with mild-to-moderate OAG and visually significant cataract.

METHODS

One hundred fourteen eyes of 114 patients were randomized to phacoemulsification and microLOT (Phaco-microLOT) (n = 57) or phacoemulsification alone (n = 57).

MAIN OUTCOME MEASURES

Intraocular pressure (IOP), antiglaucoma medication (AGM) burden, best-corrected visual acuity, surgical success, and complications were assessed through 24 months. Success was defined as a combination of at least 20%, 25%, or 30% reduction in IOP and an absolute IOP of less than 21, 18, or 15 mmHg, respectively (criteria 1, 2, and 3).

RESULTS

At 24 months, 99 patients out of the original cohort of 114 patients were analyzed (group 1 = 50; group 2 = 49). The mean IOP decreased from 26.5 ± 5.2 to 15.2 ± 4.9 mmHg in the Phaco-microLOT group and from 25.3 ± 3.1 to 18.2 ± 2.8 mmHg in the phaco-alone group (P < 0.001). The percentage IOP reduction was significantly greater in group 1 (42.6% vs. 28.1%, P = 0.004). In group 1, the mean (standard deviation) AGM used preoperatively was 0.6 (0.9), which significantly decreased to 0.2 (0.4) at 24 months, whereas in group 2, it marginally increased from 1.4 (0.6) to 1.5 (0.9). Overall success (complete + qualified) in group 1 using criteria 1, 2, and 3 was 83.3%, 72.9%, and 43.8%, whereas in group 2 it was 57.8%, 40%, and 20%, respectively. The risk of failure in group 2 was 2.87 times higher. No additional complications were observed, and no interventions were required between 12 and 24 months of follow-up.

CONCLUSIONS

Phacoemulsification and microLOT achieved sustained and superior IOP and medication reduction at 24 months, with a favorable safety profile compared to the phacoemulsification alone group. These results underscore the long-term role of microLOT for OAG. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.