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

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.

Study Start Date

September, 20 2017

Estimated Completion Date

June 2019

Interventions

  • Device: KeraKlear Non-Penetrating Keratoprosthesis

Study ID

KeraMed, Inc. -- KERA002

Status

Recruiting

Trial ID

NCT03126903

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

35

Sponsor

KeraMed, Inc.

Inclusion Criteria

  • Corneal blindness where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia or due to 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.

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.
  • 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 either eye (including retinal detachment repair, intravitreal injection, etc.).
  • 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.
  • 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.

Gender

All

Ages

22 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (11)

Study Location Distance Name Phone Email
Massachussetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Roberto Pineda MD 617-573-6971 roberto_pineda@meei.harvard.edu
Massachussetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Roberto Pineda MD 617-573-6971 roberto_pineda@meei.harvard.edu
Massachussetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Roberto Pineda MD 617-573-6971 roberto_pineda@meei.harvard.edu
Massachussetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Roberto Pineda MD 617-573-6971 roberto_pineda@meei.harvard.edu
Massachussetts Eye and Ear Infirmary - Boston, Massachusetts 2.8 miles Roberto Pineda MD 617-573-6971 roberto_pineda@meei.harvard.edu
University of Illinois at Chicago - Chicago, Illinois 851.3 miles Roxana Toh 312-355-4866 rtoh@uic.edu
University of California Irvine - Irvine, California 2,587.5 miles Herlinda Bergman CCRP 714-456-7090 hbergman@uci.edu
University of California Irvine - Irvine, California 2,587.5 miles Herlinda Bergman CCRP 714-456-7090 hbergman@uci.edu
University of California Irvine - Irvine, California 2,587.5 miles Herlinda Bergman CCRP 714-456-7090 hbergman@uci.edu
University of California Irvine - Irvine, California 2,587.5 miles Herlinda Bergman CCRP 714-456-7090 hbergman@uci.edu
University of California Irvine - Irvine, California 2,587.5 miles Herlinda Bergman CCRP 714-456-7090 hbergman@uci.edu

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