Posters

XEN implant gel: clinical results and learning curve about our first 100 cases

Poster Details

First Author: A.Grise-Dulac FRANCE

Co Author(s):    P. Nguyen   J. Laloum   M. Duong   E. Orng   I. Cochereau   D. Gatinel     

Abstract Details

Purpose:

The aim of this study was to measure the effectiveness of the new minimally invasive Xen-Gel glaucoma surgery device on the reduction of intraocular pressure, its safety and the learning curve for this new surgical technique.

Setting:

We performed a non-randomized prospective clinical study of the first 100 eyes with chronic open-angle glaucoma that benefited from XEN-Gel 45 implantation at the Rothschild Foundation, Paris, France. The study started on 01/04/2017 and has so far included 100 eyes of 84 patients.

Methods:

XEN-Gel is a gelatin tube implanted internally to create a passage from the anterior chamber to the subconjunctival space. Preoperative and postoperative IOP at D1, D7, M1, M3 and M6 were measured. The number of drugs used before and after the surgery and the per and post-operative complications encountered were collected. The operating and immobilizing time of the hall were quantified. Results at M12 will be known in April 2018. Mean age of the patients was 70.70 +/- 9.65 years with a balanced sex ratio. Glaucoma was moderate with mean MD at -10.89dB.

Results:

Preoperative intraocular pressure was 22 +/- 9.32 mmHg with 2.44 +/- 1.09 molecules. The IOP was 7.4 +/- 2.3mmHg at day 1, 8.3 +/- 3.75mmHg at day 7, 14.65 +/- 8.6mmHg at M1, 15.67 +/- 9.2 mmHg at M3 and 15.4 +/- 9.5 mmHg to M6. Intraoperative complications were rare and not serious: angular haemorrhage (17%), subconjunctival haemorrhage (9.5%), tube removed and replaced (8%). The needling rate was 13.1%. Average operating time was 15.33 +/- 7.66 min. Linear regression analysis revealed a learning effect with a decrease of operating time and number of intraoperative complications.

Conclusions:

These first results show an effectiveness of the XEN-Gel implant on IOP. Intraoperative complications were rare and without significant repercussions. The needling rate was low. The regression analysis shows a real learning curve of the surgical procedure. A longer-term study and a larger number of patients will clarify these results and determine the positioning of the XEN-Gel implant in the therapeutic arsenal of Glaucoma.

Financial Disclosure:

None