The XEN45 Gel Stent as a minimally invasive procedure in glaucoma surgery: success rates, risk profile, and rates of re-surgery after 261 surgeries.

PURPOSE: The XEN45 Gel Stent is a flexible hydrophilic tube placed under the conjunctiva via the anterior chamber. This study investigates the IOP (intraocular pressure)-lowering potential, the risk profile, and the success rate of the XEN45 Gel Stent.

METHODS: Two hundred and sixty-one eyes underwent surgery. The mean follow-up time was 8.5 months. The aim of the treatment was to achieve adequate IOP reduction without medication. Therefore, all patients who did not show sufficiently reduced IOP underwent a surgical revision with opening of the conjunctiva. To determinate the success rate, we carried out two kinds of analysis: 1) the primary success rate: eyes with appropiate IOP control without medication or surgical revision, and 2) overall success rate: one surgical revision was allowed.

RESULTS: Intraocular pressure was lowered from 24.3 mmHg (SD 6.6) to 16.8 mmHg (SD 7.6), and the medication score was lowered from 2.6 (SD 1.1) to 0.2 (SD 0.7). Revisional surgery was performed in 80 eyes (34%). After a first revision, intraocular pressure was lowered to 14.0 mmHg (SD 5.1), and the medication score was lowered to 0.2 (SD 0.6). The primary success rate was 66% and the overall success rate 90%. The primary success rate was higher in pseudophakic eyes (73%) than in phakic eyes (53%) or combined surgery (55%).

CONCLUSIONS: We conclude from our data that the XEN45 Gel Stent has an IOP-lowering potential and few side-effects. Pseudophakic eyes seem to have a better primary prognosis compared to combined surgery or surgery in phakic eyes.