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Keratoprosthesis
CorNeat KPro for Corneal Blindness
N/A
Recruiting
Research Sponsored by CorNeat Vision Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged ≥ 21 and ≤ 80 years on the day of screening
Legally blind (BCVA of 6/120 or worse in the better eye) in one or two eyes. In case of unilateral blindness - BCVA of Counting Fingers (CF) from 1 meter or worse in the operated eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-op
Awards & highlights
Study Summary
This trial tests a new eye device to help restore vision in those with corneal blindness.
Who is the study for?
Adults aged 21-80 with legal blindness due to corneal diseases, who've had unsuccessful corneal transplants or aren't candidates for them. Must be able to follow study procedures and have adequate tear film and lid function. Women of childbearing age must use contraception.Check my eligibility
What is being tested?
The trial is testing the CorNeat KPro, a device designed as a treatment for corneal blindness. This single-arm study involves multiple centers and doesn't compare against other treatments but measures safety and performance in eligible participants.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include those typical of eye surgeries such as infection, inflammation, increased intraocular pressure, or rejection of the device leading to further vision loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Select...
I am legally blind in one or both eyes.
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I need a special cornea surgery because regular cornea transplants have failed or are not suitable for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Assessment
Secondary outcome measures
Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline
Retention rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: CorNeat KProExperimental Treatment1 Intervention
Intraocular implantation of the CorNeat KPro
Find a Location
Who is running the clinical trial?
CorNeat Vision Ltd.Lead Sponsor
3 Previous Clinical Trials
98 Total Patients Enrolled
1 Trials studying Corneal Diseases
10 Patients Enrolled for Corneal Diseases
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been told I'm not a good candidate for corneal transplant due to conditions like herpetic keratitis or Steven Johnson Syndrome.My diabetes is not well-controlled, with an HbA1c over 8%.I need continuous anticoagulation treatment that can't be stopped for surgery.I currently have an infection and am taking antibiotics.I am a good candidate for traditional cornea transplant surgery.You have had a bad reaction to numbing creams, eye-dilating drops, or any part of the medical device.My doctor expects I have less than two years to live due to my illness.My corneal thickness is either below 400 or above 1200 microns.I have been diagnosed with ocular ischemic syndrome.I have a corneal disorder, but it's not in the central part of my eye.I had no surgery issues that would stop me from getting the study device.I am between 21 and 80 years old.I can attend all visits and follow study rules.I am not pregnant and agree to use birth control during the study.I have a working eye pressure control device or surgery.My eyes produce enough tears and my eyelids work well.I am currently experiencing a detached retina.My target eye has connective tissue disease or severe scarring.I have advanced or uncontrolled glaucoma.I have had severe eye inflammation diseases.I have had cancer in or around my eye.I have active eye inflammation.You have a history of developing large, raised scars called keloids.Your doctor thinks that you have a health condition that could make it risky for you to have the device placed.People who are under 18, pregnant, in prison, work for the company sponsoring the study, in the military, very ill, in a coma, have physical or intellectual challenges, are in an institution, or are refugees.I am legally blind in one or both eyes.I need a special cornea surgery because regular cornea transplants have failed or are not suitable for me.Ability to see light in all areas of vision.
Research Study Groups:
This trial has the following groups:- Group 1: CorNeat KPro
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the research protocol include minors in its participant criteria?
"The target participants for this trial are those aged 21 or above, but not exceeding 80 years."
Answered by AI
Are there still vacancies for prospective participants in this research trial?
"This clinical trial, which was initially posted on March 1st 2023 and last edited on January 12th of the same year, is not presently recruiting participants according to its entry in clinicaltrials.gov. However, 43 other studies are currently enrolling patients."
Answered by AI
Who meets the eligibility requirements for this exploration?
"This trial is in search of 40 individuals between the ages 21 and 80 who suffer from corneal diseases. To qualify, they must be male or female; possess legal blindness (BCVA 6/120 or worse) in one ore more eyes; have adequate tear film production and lid function; demonstrate perception of light across all quadrants; females of childbearing age need to present a negative pregnancy test at screening and agree to utilize an effective contraceptive method during the study period. Furthermore, prospective participants must be willing to attend all scheduled visits as well as comply with every protocol related procedure. Lastly, those for whom keratoplasty is not"
Answered by AI
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