Status:
WITHDRAWN
Implantable Intraocular Pressure Sensor for Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Implandata Ophthalmic Products GmbH
Conditions:
Glaucoma
Blindness, Acquired
Eligibility:
All Genders
18-80 years
Phase:
NA
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 per...
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 per...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03421548
Start Date
November 1 2016
End Date
June 1 2020
Last Update
February 5 2018
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