search
Back to results

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

Primary Purpose

Glaucoma, Blindness, Acquired, Keratitis, Herpetic

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EyeMate
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    BKpro I with EyeMate

    BKpro I

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    IOP data gathering
    • To collect IOP data with the PRO-IOP system and evaluate the performance of the PRO-IOP system in the first 24 months following implantation. This will be compared to digital palpation and tonopen.

    Secondary Outcome Measures

    Relationship between IOP data and determinants factors of glaucoma
    To determine the relationship between the IOP data with the use of the EyeMate system and the evolution of the other determinant factors of glaucoma through a correlation analysis of IOP with the characteristics and evolution of the optic nerve, visual fields, and OCT of the peripapillary retinal nerve fiber layers in patients with BKPRO type 1.
    Safety and tolerability of the EyeMate sensor
    To evaluate the safety and tolerability of the EyeMate pressure sensor and record adverse effects 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 PRO-IOP pressure sensor. Recording of incidence of device deficiencies at day 1 and at months 1, 4, 8, 12, 16, 20, 24 following implantation.

    Full Information

    First Posted
    August 1, 2017
    Last Updated
    January 29, 2018
    Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
    Collaborators
    Implandata Ophthalmic Products GmbH
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03421548
    Brief Title
    Implantable Intraocular Pressure Sensor for Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1
    Acronym
    BKPro
    Official Title
    Intraocular Pressure Monitoring With Implantable Intraocular Pressure Sensor for Improved Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The product company withdrawn interest in participation in this study
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre hospitalier de l'Université de Montréal (CHUM)
    Collaborators
    Implandata Ophthalmic Products GmbH

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Blindness, Acquired, Keratitis, Herpetic, Ocular Cicatricial Pemphigoid, Corneal Injuries, Corneal Disease, Corneal Opacity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BKpro I with EyeMate
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    BKpro I
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    EyeMate
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    IOP data gathering
    Description
    • To collect IOP data with the PRO-IOP system and evaluate the performance of the PRO-IOP system in the first 24 months following implantation. This will be compared to digital palpation and tonopen.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Relationship between IOP data and determinants factors of glaucoma
    Description
    To determine the relationship between the IOP data with the use of the EyeMate system and the evolution of the other determinant factors of glaucoma through a correlation analysis of IOP with the characteristics and evolution of the optic nerve, visual fields, and OCT of the peripapillary retinal nerve fiber layers in patients with BKPRO type 1.
    Time Frame
    24 months
    Title
    Safety and tolerability of the EyeMate sensor
    Description
    To evaluate the safety and tolerability of the EyeMate pressure sensor and record adverse effects 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 PRO-IOP pressure sensor. Recording of incidence of device deficiencies at day 1 and at months 1, 4, 8, 12, 16, 20, 24 following implantation.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Ability and willingness to attend all scheduled visits and comply with all study procedures. Exclusion Criteria: Reasonable chance of success with traditional keratoplasty. Current retinal detachment Connective tissue diseases 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 History of ocular or periocular malignancy Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, or silicone (component of the device) Presence of another active medical eye implant and/or other active medical implants in the head/neck region Signs of current infection, including fever and current treatment with antibiotics Severe generalized disease that results in a life expectancy shorter than a year Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device Currently pregnant or breastfeeding 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 Intraoperative complication that would preclude implantation of the study device 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. Previous or concurrent enrollment of the contralateral eye in this clinical study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mona Harissi-Dagher, MD
    Organizational Affiliation
    CHUM
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs