Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04485858
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged ≥ 18 and ≤ 80 years on the day of screening
* Candidates must have the ability and willingness to attend all scheduled visits and comply with all study procedures
* Keratoprosthesis surgery is indicated in cases when keratoplasty is not a reasonable option or following a verifiable history of prior failed corneal transplantation
* Indications that fall under poor candidate for keratoplasty include but are not limited to: herpetic keratitis, vascularized corneal scar, Ocular Cicatricial Pemphigoid, alkali burn, Steven Johnson Syndrome, and limbal stem cell deficiency
* Pseudophakia
* Adequate tear film and lid function
* Perception of light in all quadrants
* Female patients of childbearing age must have negative pregnancy test at screening and agree to use an effective method of contraception throughout the study
Exclusion Criteria:
* Reasonable chance of success with traditional keratoplasty
* Current retinal detachment
* Connective tissue diseases
* End-stage glaucoma
* History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to planned implantation
* History of ocular or periocular malignancy
* History of extensive keloid formation
* Any known intolerance or hypersensitivity to topical anaesthetics, mydriatics, or component of the device
* 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
* Corneal thickness less than 400 or higher than 1,200 microns in any region of the pachymetry map of the eye intended to be operated
* Currently pregnant or breastfeeding
* Participation in any study involving an investigational drug or device within the past 30 days or 5 half-lives of the drug (whichever longer) or ongoing participation in a study with an investigational drug or device
* Intraoperative complication that would preclude implantation of the study device
* Vulnerable populations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04485858
Study Brief:
Protocol Section:
NCT04485858