Objective: To evaluate the safety and the efficacy of a stainless steel miniature glaucoma device (Ex-PRESS™, manufactured by Optonol, Israel) in reducing the intra-ocular pressure in eyes affected by primary open-angle glaucoma.
Patients and
method: A prospective multi-center
study included 98 eyes of Caucasian patients with open-angle glaucoma (48 eyes
after failed medical therapy, 21 eyes after failed trabeculectomy and 29 eyes
in combination with cataract surgery). Data on safety are reported for all the
patients.Efficacy data are on 44eyes implanted with a fixed resistance device
(50 micron lumen). Results: The duration of the implantation procedure
was less than 5 minutes. Mean follow up is 6 months. The IOP decreased from
29.67±1.67 (44 eyes) preoperatively to 16.21±1.11 at 26 weeks (29 eyes) and
14.67±0.7 (9 eyes)at one year. The number of antiglaucoma medication changed
from 1.57±0.13 to 0.26±0.1 medications at 6 months.At 52 weeks, only one
patient out of nine is under one medication. In 98 eyes implanted with the
different lumen (20, 30, 50 microns) there were 2 cases (2%) of flat anterior
chamber and 6 cases (6%) of transient shallow anterior chamber, 8 cases of
transient choroidal detachment (3
required anterior chamber reformation). During follow up there was one
case (3%) of conjunctival erosion
2 cases were explanted and one was treated with conjunctival suture)
,8eyes needed repeated glaucoma surgery for further IOP reduction (8 %) None of
the patients developed inflammation, infection, extrusion 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 filtration surgery.
Our data show that this implant is reasonably safe and very effective in the
short term.