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

NCT ID: NCT03421548

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BKpro I with EyeMate

Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation.

Group Type: EXPERIMENTAL

EyeMate

Intervention Type: DEVICE

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.

BKpro I

Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely. Potential study subjects will be solicited for participation in the clinical trial only after they have consented to the keratoprosthesis operation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Keratoprosthesis surgery indicated, defined as having a severely opaque and vascularised cornea AND either a verifiable history of two or more prior failed corneal transplant procedures, limbal stem cells deficiency or a medical condition such as alkali burns or autoimmune disease that makes the success of a traditional corneal transplant procedure unlikely.

2. Ability and willingness to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria

1. Reasonable chance of success with traditional keratoplasty.

2. Current retinal detachment

3. Connective tissue diseases

4. History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to PRO-IOP implantation

5. History of ocular or periocular malignancy

6. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device)

7. Presence of another active medical eye implant and/or other active medical implants in the head/neck region

8. Signs of current infection, including fever and current treatment with antibiotics

9. Severe generalized disease that results in a life expectancy shorter than a year

10. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device

11. Currently pregnant or breastfeeding

12. Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device

13. Intraoperative complication that would preclude implantation of the study device

14. Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.

15. Previous or concurrent enrollment of the contralateral eye in this clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Implandata Ophthalmic Products GmbH

INDUSTRY

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mona Harissi-Dagher, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Other Identifiers

2016-6261

Identifier Type: -

Identifier Source: org_study_id