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

NCT03126903 | Terminated FDA Device

• 2 other identifiers: KERA0021R44EY021664-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 4

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.

Conditions

Corneal Blindness

Outcome Measures

Primary Outcomes (1)

• Improvement in BCDVA compared to baseline

  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.

  Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12

Study Arms (1)

Single-Arm

EXPERIMENTAL

KeraKlear Non-Penetrating Keratoprosthesis

Device: KeraKlear Non-Penetrating Keratoprosthesis

Interventions

KeraKlear Non-Penetrating Keratoprosthesis DEVICE

The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity.

Single-Arm

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Corneal blindness where cornea transplantation is necessary but with a high risk of graft failure due to
• severe limbal stem cell deficiency (LSCD) associated with aniridia or
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KeraMed, Inc.: lead
• National Eye Institute (NEI): collaborator
• ClinReg Consulting Services, Inc.: collaborator

Study Sites (4)

University of California Irvine

Irvine, California, 92697, United States

Location

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

Massachussetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Duke University School of Medicine - Dept. of Ophthalmology

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Kilian R, Lammer J, Roberts P, Rizzo C, Pedrotti E, Marchini G, Schmidinger G. Nonpenetrating Foldable Intrastromal Keratoprosthesis: A Review of the Literature. Cornea. 2024 Jul 1;43(7):909-915. doi: 10.1097/ICO.0000000000003500. Epub 2024 Feb 21.

  PMID: 38381061 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open-label clinical trial

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: March 22, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)