One and two year results comparing phakic, pseudophakic and combined with cataract surgery cases for the InnFocus MicroShunt®

Session Details

Session Title: Glaucoma I

Session Date/Time: Sunday 11/09/2016 | 14:30-16:00

Paper Time: 15:54

Venue: Auditorium C6

First Author: : I.Riss FRANCE

Co Author(s): :    J. Battle   L. Pinchuk   Y. Kato   B. Weber   J. Parel        

Abstract Details

Purpose:

There is an unmet need for a simple-to-implant, minimally invasive glaucoma shunt with intraocular pressure (IOP) reduction similar to trabeculectomy. The InnFocus MicroShunt® has previously been shown to satisfy this requirement. The purpose of this study was to determine the differences in intraocular pressure and medications/patient at one and two years in eyes that, prior to surgery, were either phakic, pseudophakic or phakic with combined phacoemulsification and intraocular lens placement.

Setting:

Two centers; 1) Bordeaux, France and 2) Santo Domingo, Dominican Republic.

Methods:

Retrospective 2-year study of 79 consecutive trabeculectomy-stage eyes with open angle glaucoma, that were either phakic, pseudophakic or phakic and required cataract surgery at the time of implantation of the MicroShunt. The MicroShunt is an 8.5 mm long, 0.35 mm in diameter tube made from SIBS with a lumen diameter of 70 µm. It shunts aqueous humor from the anterior chamber to a bleb formed under the conjunctiva/Tenons. All MicroShunts implanted ab externo through a 25-G needle tract formed after exposure of the sub conjunctival/Tenons flap to Mitomycin C (0.2 to 0.4 mg/ml, 2-3 min) followed by rinsing.

Results:

For phakic, pseudophakic and combined cases, the pre-operative medicated IOPs were 23.5±5.4 (N=30), 25.2±7.2 (N=31) and 26.2±5.2 (N=18) mm Hg; medications/patient were 2.3±1.1, 2.4±1.3 and 2.1±1.2, respectively. At Year-1, the IOPs were 13.8±3.3 (N=24), 13.7±5.4 (N=23) and 11.9±3.3 (N=18) mm Hg; medications/patient were 0.1±0.4, 0.8±1.2 and 0.4±0.9, respectively. At Year-2, the IOPs were 13.4±4.1 (N=11), 12.0±5 (N=11) and 13.3±5.0 (N=12) mm Hg; medications/patient were 0.7±1.3, 1.0±1.3 and 0.1±0.3, respectively. The p values ranged from 0.06 to 0.95 implying no significant differences between any of the groups (null hypothesis set to <0.05). There were no long-term sight-threatening adverse events.

Conclusions:

There were no significant differences in IOP and medications/patient at one and two years in eyes that were phakic, pseudophakic and combined with cataract surgery at the time of implant. The overall reduction in IOP at 1 and 2 years was 47% and 48%; the overall reduction in medications/patient were 81% and 74%, respectively. There were no long-term sight-threatening adverse events. The InnFocus MicroShunt® is safe, effective and practical in eyes that are phakic, pseudophakic and require concomitant cataract surgery.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation