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Impressum
The Ex-PRESS miniature glaucoma implant: Intermediate results of a prospective multicenter Study
1Kaplan-Messas A., 2Traverso C., 3Belkin M., The International Ex-PRESS™ Study group
1Ophthalmology Department, Barzilai Medical Center, Ashkelon, Israel; 2DSNV Ophthalmology Section B, University of Genova, Italien; 3Goldshleger Eye Research Institute, Shiba Medical Center, Tel Aviv, Israel
Objective: To evaluate the safety and the efficacy of a stainless
steel miniature glaucoma device (Ex-PRESS™ ) in reducing the intra-ocular
pressure in eyes affected by primary open-angle glaucoma.
Patients and method: A phase II prospective multi-center case series
included 108 eyes of Caucasian patients with open-angle glaucoma. The
miniature (3mm) stainless steel tube like implant was inserted at the
limbus of 49 naïve eyes, 22 eyes after failed trabeculectomy and
37 eyes in combination with cataract surgery. Antimetabolites were not
used as adjunctive peroperative therapy even in eyes after failed trabeculectomy.
Three versions of the device were studied corresponding to an internal
lumen of 20, 30 and 50 microns. The Data on safety are reported for all
the patients. Efficacy data are reported on 43 eyes implanted with the
optimal internal lumen: 50 micron.
Results: The duration of the implantation procedure was less than
5 minutes. Mean follow up was 31 weeks. The IOP decreased from 29.7±
1.7 (43 eyes) preoperatively to 16.2±1.1 at 26 weeks (29 eyes)
and 14.7±0.7 (9 eyes) at one year. The number of antiglaucoma medication
changed from 1.7 ± 0.1 to 0.25 ± 0.1 medications at 6 months.
At 52 weeks, only one out of nine eyes is under one medication. In 108
eyes (implanted with 3 different lumen size implants) 4 cases (3.7%) developed
a flat anterior chamber with choroidal detachment and 7 cases (6.5%) a
transient shallow anterior chamber (only 3 required anterior chamber reformation
with visco-elastic). During follow up 6 eyes experienced (5.6%) conjunctival
erosion, 3 of them were explanted and 2 resolved by conjunctival suture.
Needling or bleb revision were performed in 20 cases (18.5%).5 eyes needed
glaucoma surgery for further IOP reduction (11.6%). None of the patients
developed inflammation, infection, or irreversible damage to the eye.
Conclusions: The early results obtained with this implant support
the continuation of clinical trials to assess its role as a substitute
for filtering surgery. Our data show that this implant is reasonably safe
and very effective in the short term.