WithdrawnNot Applicable

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

Stopped: The product company withdrawn interest in participation in this study

0Started 2016-11

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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

What they're measuring

IOP data gathering

Timeframe: 24 months

Trial details

NCT IDNCT03421548

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

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