Glaucoma Clinical Trial
— BKProOfficial title:
Intraocular Pressure Monitoring With Implantable Intraocular Pressure Sensor for Improved Glaucoma Monitoring in Patients With Boston Keratoprosthesis Type 1
Verified date | April 2016 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | Implandata Ophthalmic Products GmbH |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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. | 24 months |
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