NCT03421548

Implantable Intraocular Pressure Sensor for Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1

Intraocular Pressure Monitoring With Implantable Intraocular Pressure Sensor for Improved Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma
• Blindness, Acquired
• Keratitis, Herpetic
• Ocular Cicatricial Pemphigoid
• Corneal Injuries
• Corneal Disease
• Corneal Opacity

Interventions

Type	Name	Description
DEVICE	EyeMate	Patients will undergo implantation BKPro with concomitant implantation of the EyeMate pressure sensor. The surgical approach will involve a trephination of the central recipient cornea of adequate size. In subjects with adequate capsular support, the sensor device will be placed in the sulcus space by grasping the sensor's silicone sleeve at approximately the 3 and 9 o'clock positions and sliding it into the sulcus space. In subjects in whom capsular support is inadequate, the Eyemate implant will be sutured to the sclera. This is performed by placing an 8-O Gortex suture or 9-O prolene on CIF-4 needles around the antenna at the 2 and 7 o'clock positions and suturing the device to the sclera using an ab-interno technique.

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-01-01
• Completion: 2020-06-01
• First posted: 2018-02-05
• Last updated: 2018-02-05