Efficacy and Safety of Ab Externo Open Conjunctiva XEN® 63 µm Implantation with a 30G Needle Scleral Tract in Primary Open-Angle Glaucoma.

Background: This study aimed to assess the efficacy and safety of the 30G needle mediated ab externo open conjunctiva approach for the XEN 63 µm implant in primary open-angle glaucoma. Methods: A retrospective and non-randomized study was conducted on consecutive cases of medically refractory primary open-angle glaucoma treated with standalone ab externo open conjunctiva XEN® 63 µm (North Chicago, Illinois) with one-year follow-up. Results: Twenty-two eyes were included. The mean preoperative intraocular pressure was 21.9 ± 7.2 mmHg, and the mean number of glaucoma medications was 2.4 ± 0.9. All patients underwent mitomycin 0.02% application for 2 min, and Healaflow® (MedicalMix, Spain), was implanted in 11 cases (50%). Complete surgical success was achieved in 14 cases (63.6%). No statistical differences in complete surgical success were noted based on the use of Healaflow®. A significant reduction in intraocular pressure (11.8 ± 3.4 mmHg) and in the number of hypotensive medications (0.2 ± 0.5 mmHg) was observed 1 year after the procedure. Transient hypotony was detected in 31.8% of cases. Complications secondary to hypotony included four cases of serous choroidal detachment and one case of localized hemorrhagic choroidal detachment, the latter associated with hypotonic keratopathy and hypotonic maculopathy. All these complications evolved favorably with conservative management and adjusted topical treatment. Conclusions: This study highlights the efficacy and safety of this approach for the XEN 63 µm implant in medically refractory primary open-angle glaucoma.