Glaucoma Clinical Trial
Official title:
Intraocular Pressure Monitoring With Implantable Intraocular Pressure Sensor for Improved Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1
The purpose of this study is to evaluate the safety and performance of the EYEMATE system in patients undergoing concomitant implantation of a BKPro type 1 and an EYEMATE sensor over the 24 months period beginning at implantation.
The purpose of this study is to evaluate the safety and performance of the EYEMATE system in
patients undergoing concomitant implantation of a BKPro type 1 and an EYEMATE sensor over the
24 months period beginning at implantation. The EYEMATE system involves an EYEMATE
implantable sensor working together with a MESOGRAPH hand-held reading device. The aim of
this investigation is to collect intraocular pressure data with the EYEMATE pressure sensor
in patients with BKPRO type and determine the relationship between the following glaucoma
characteristics: intraocular pressure, characteristics and evolution of the optic nerve,
visual fields, and OCT of the optic nerve. The intraocular pressure will be measured by three
means. First, there will be mapping of the diurnal fluctuation of IOP with daily IOP
self-measurement profiles with the EYEMATE system (subjects). Secondly, there will be mapping
of fluctuation of IOP measurements with the EYEMATE system (site staff). Thirdly, the IOP
will be evaluated through the measurement of the Schiotz tonometer on the limbal conjunctiva.
The primary performance objective is to collect IOP data with the EYEMATE system and compare
the level of agreement between IOP measurements made using schiotz tonometry and the EYEMATE
system over the first 24 months following implantation. The secondary performance objective
is to determine the relationship between the IOP data with the use of the EYEMATE system and
the progression of glaucoma through the evaluation of the characteristics of the optic nerve,
visual fields, and OCT of the peripapillary retinal nerve fiber layers in patients with BKPRO
type 1. The secondary safety objective is to evaluate the safety and tolerability of the
EYEMATE pressure sensor, record adverse effects and incidence of device deficiencies in the
first 24 months through the recording of incidence, nature, seriousness, severity and
duration of adverse events at day 1 and at months 1, 4, 8, 12, 16, 20, 24 following
implantation of the EYEMATE pressure sensor.
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