Multicenter 3 year results of 800 glaucoma eyes treated with minimally invasive gel microstent with ab-interno approach to subconjunctival space

Session Details

Session Title: Glaucoma II

Session Date/Time: Tuesday 08/09/2015 | 08:00-10:30

Paper Time: 09:32

Venue: Room 17

First Author: : I.Kersten-Gomez GERMANY

Co Author(s): :    H. Reitsamer   H. Dick                 

Abstract Details

Purpose:

To describe the up to 36 months results from a novel, soft and permanent, minimally invasive ab interno collagen implant used to optimize aqueous drainage to the subconjunctival space. The goal of the implant is to lower IOP through subconjunctival filtration without the early postoperative risk of complications associated with conjunctival incisions.

Setting:

In this prospective, non-randomized, multi-center evaluation conducted in 13 countries with over 40 investigators, 800 eyes were implanted with a XEN gel stent and followed up to 36 months. This data set incorporates 3 inner lumen sizes of the same gel stent (140, 63, 45 µm). The data was collected in 10 countries (Austria, Belgium, Canada, Germany, Italy, Poland, Spain, Switzerland, UK, and Venezuela) with 20 surgeons in hospital and private practices, including our University Eye Hospital of Bochum, Germany.

Methods:

800 eyes were implanted with a XEN gel stent and followed up to 36 months. During surgery a trans-scleral gelatin stent is placed through a self-sealing corneal incision using a preloaded injector. All patients had mild, moderate, severe or refractory OAG. 57% were solo procedures , 43% were combined with cataract surgery. A low dose of MMC was injected prior to surgery in 75% (597 eyes). Mean IOP, IOP change, reduction in medications, conversions and safety were recorded in all subjects, of which some have reached 36 months postoperative examination.

Results:

Mean preoperative (best-medicated) IOP for all eyes was 21.9 ± 5.3 mmHg. The mean postoperative IOPs were: 15.2 ± 5.2 at 12 months (-30% reduction; n=197), 15.0 ± 4.5 at 24 months (-31% reduction; n=68), and 13.3 ± 2.9 at 36 Months (-40% reduction; n=31). At 12 months anti-glaucomatous medications were reduced by 64% from the preoperative mean of 2.5 (patients not washed out pre-surgery), by 56% at 36 months. To date 23 eyes (3%) were converted to another procedure at 12 months, 30 eyes ( 4%) at 36 months. The results of solo compared with combined procedures did not differ significantly.

Conclusions:

All three lumen sizes (140, 63, 45 um) received CE Mark in 2011. The IOP reduction was 30 % at 12 months, 31% at 24 and 40% at 36 months. The antiglaucomatous medications were reduced by 64% at 12 months and 56 % at 36 months compared to baseline. The minimally-invasive conjunctiva sparing approach of this broadly adoptable implant procedure was a safe and effective approach to controlling IOP and reducing medications in patients.

Financial Interest:

One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented