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A Clinical Study to Evaluate the KeraKlear Keratoprosthesis in Patients With Corneal Opacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03126903
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
National Eye Institute (NEI)
ClinReg Consulting Services, Inc.
Information provided by (Responsible Party):
KeraMed, Inc.

Brief Summary:
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK.

Condition or disease Intervention/treatment Phase
Corneal Blindness Device: KeraKlear Non-Penetrating Keratoprosthesis Not Applicable

Detailed Description:
To evaluate the safety and probable benefit of the KeraKlear Non-Penetrating Keratoprosthesis when implanted in an eye with corneal opacity that is at high risk of complications with PK. A prospective, multicenter, clinical trial, designed to demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Probable Benefit of the KeraKlear Non-Penetrating Keratoprosthesis in Subjects With Corneal Opacity With Poor Prognosis for Corneal Transplant
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
Experimental: Single-Arm
KeraKlear Non-Penetrating Keratoprosthesis
Device: KeraKlear Non-Penetrating Keratoprosthesis
The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity.




Primary Outcome Measures :
  1. Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ]
    Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Corneal blindness where cornea transplantation is necessary but with a high risk of graft failure due to

    1. severe limbal stem cell deficiency (LSCD) associated with aniridia or
    2. one full-thickness graft failure and at high risk of a failed second graft; specifically, those who have either young recipient age (age less than 40 years), a history of anterior segment surgery (in addition to prior PKP), and/or pre-operative glaucoma or
    3. multiple (two or more) failed cornea transplantation surgeries and spontaneous visual improvement without surgical intervention is not expected or probable.
  • Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in the study eye (but at least light perception with projection)
  • Estimated visual potential of the study eye is greater than or equal to at least two lines visual improvement of BCDVA of current vision in the study eye.
  • Patient and/or caregiver willing and able to insert and remove bandage contact lens.

Exclusion Criteria:

  • Visual Acuity of No Light Perception (NLP) in the study eye
  • The patient is monocular or the non-study eye has Best Corrected Distance Visual Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe aniridic limbal stem cell deficiency or failed cornea transplantation surgery(ies).
  • Suitable for standard PK with donor tissue in the study eye.
  • History of severe dry eye syndrome or a Schirmer test with results of less than 3mm after 5 minutes of testing with the use of topical anesthetic in either eye.
  • Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis, etc.).
  • On medications that may affect wound healing, such as antimetabolites or other chemotherapeutic agents.
  • History of posterior segment eye disease in either eye (including macular degeneration, optic neuropathy, posterior uveitis) which is expected to limit the visual improvement to less than two lines of vision.
  • History of retinal surgery in the fellow eye (including retinal detachment repair, intravitreal injection etc.).
  • History of retinal surgery in the study eye (including retinal detachment repair, intravitreal injection, etc.) unless the vision is at least light perception with projection in four field quadrants and the macula is attached (if there is no view of the retina, an ultrasound must show the macula is attached).
  • History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at any time in the last 6 months).
  • Current use of beta blocker eye drops (e.g. timolol, levobunolol, etc.).
  • Vertical cup-to-disc (C:D) ratio greater than or equal to 0.8 in either eye (if able to visible through corneal opacity). If not visible, patient is not to be excluded.
  • Limited visual potential (patient does not have the ability to improve a minimum of two lines of vision of BCDVA by history).
  • History of amblyopia in the study eye limiting visual potential.
  • If the patient has had a corneal transplant, corneal transplantation surgery was performed less than 2 years ago.
  • Anticipated need for surgery on the study eye during the course of the study (including cataract surgery).
  • Aphakia in the study eye.
  • Active ocular infection in either eye.
  • Hypotony in the study eye (IOP < 6mmHg).
  • History of herpetic ocular infection in the study eye.
  • Corneal thickness less than 400 microns in any region of the pachymetry map, i.e.

lamellar resection depth would be <100 microns from corneal endothelium accounting for the optic height of the selected implant design (i.e. 300 microns for KeraKlear or 500 microns for KeraKlear XT model).*.

  • Inability to protect the operated eye from trauma.
  • Females who are pregnant, lactating, or unwilling to use adequate birth control for t the duration of the study.
  • Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126903


Contacts
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Contact: Gretchen Neumann, M.S. 949-466-7124 Gretchen@clinregconsulting.com
Contact: Yichieh "EJ" Shiuey, M.D. 973-276-1414 yshiuey@keramed.com

Locations
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United States, California
University of California Irvine Recruiting
Irvine, California, United States, 92697
Contact: Jesi Zavala, CCRP    714-456-7090    yzavala@uci.edu   
Principal Investigator: Marjan Farid, M.D.         
United States, Illinois
University of Illinois at Chicago Withdrawn
Chicago, Illinois, United States, 60612
United States, Kentucky
Cincinnati Eye Institute Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Edward J Holland, M.D    513-984-5133    eholland@holprovision.com   
Contact: Katie Hogeback    859-331-9000 ext 4517    khogeback@cincinnatieye.com   
United States, Massachusetts
Massachussetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Roberto Pineda, M.D.    617-573-6971    roberto_pineda@meei.harvard.edu   
Contact: John Caccaviello    617-573-4436    John_Caccaviello@meei.harvard.edu   
Principal Investigator: Roberto Pineda, M.D.         
United States, North Carolina
Duke University School of Medicine - Dept. of Ophthalmology Recruiting
Durham, North Carolina, United States, 27710
Contact: Victor Perez, MD    919-684-5769    victor.perez.quinones@duke.edu   
Contact: Teresa Hawks    919-681-1569    Teresa.hawks@duke.edu   
Principal Investigator: Victor Perez, MD         
Sponsors and Collaborators
KeraMed, Inc.
National Eye Institute (NEI)
ClinReg Consulting Services, Inc.

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Responsible Party: KeraMed, Inc.
ClinicalTrials.gov Identifier: NCT03126903     History of Changes
Other Study ID Numbers: KERA002
1R44EY021664-01 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Blindness
Corneal Opacity
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Corneal Diseases