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SINGLE PATIENT EXPANDED ACCESS OF 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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03812341
Recruitment Status : Withdrawn (No enrollment)
First Posted : January 23, 2019
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Brief Summary:

This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. However, this expanded access is for single patient use below is a description of patient condition and circumstances necessitating treatment:

88 year old female with 2 previous failed corneal transplants, had significant scarring and mild edema, surface well epithelialized, has potential for 10 letters of improvement in visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore would not be a candidate for standard corneal transplant. She would potentially do well with a partial thickness artificial cornea such as the KeraKlear.


Condition or disease Intervention/treatment Phase
CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT Other: Experimental Not Applicable

Detailed Description:

For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old as of the submission of this Protocol Narrative to the IRB.

Postoperatively, subject will be examined at (with window size in parentheses):

  • 1 Day (+2 days)
  • 1 Week (7±2 days)
  • 1 Month (30±5 days)
  • 2 Months (60±7 days)
  • 3 Months (90±7 days)
  • 4 Months (120±10 days)
  • 6 Months (180±10 days)
  • 9 Months (270±20 days)
  • 12 Months (360±20 days)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SINGLE PATIENT EXPANDED ACCESS OF 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 : August 10, 2018
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 9, 2019

Intervention Details:
  • Other: Experimental
    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. 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 ] [ Time Frame: 1 year ]
    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:   88 Years to 88 Years   (Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   88 year old female.
Accepts Healthy Volunteers:   No
Criteria

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 due to an ocular condition other than severe aniridic limbal stem cell deficiency or due to multiple (two or more) failed cornea transplantation surgeries.
  • 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.
  • 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.

For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old.

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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): NCT03812341


Locations
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United States, California
University of California Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03812341    
Other Study ID Numbers: 2018-4549
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Corneal Opacity
Corneal Diseases
Eye Diseases