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Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

This study is currently recruiting participants.
Verified March 2013 by Massachusetts Eye and Ear Infirmary
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01582880
First received: April 10, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis). The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.


Condition Intervention Phase
Chemical Injuries
Unspecified Complication of Corneal Transplant
Autoimmune Diseases
Ocular Cicatricial Pemphigoid
Stevens Johnson Syndrome
Lupus Erythematosus, Systemic
Rheumatoid Arthritis
Other Autoimmune Diseases
 Drug: Riboflavin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Resource links provided by NLM:

Drug Information available for: Riboflavin
U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Changes in corneal thickness [ Time Frame: measured at week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: No ]
    Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate


Secondary Outcome Measures:
  • Lack of sterile ulcers via slit lamp [ Time Frame: post op day 1, week 1, 4, 8, 12, 16, 24, 36, 52. ] [ Designated as safety issue: No ]
  • Ocular safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: Yes ]
    incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)

  • Systemic safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ] [ Designated as safety issue: Yes ]
    incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Riboflavin Cross-linked donor cornea
the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.
 Drug: Riboflavin
Used to treat donor cornea before implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  2. Age > 18 years.
  3. A negative urine pregnancy test.
  4. Candidate for a Boston Keratoprosthesis/Corneal transplant.
  5. Generally good stable overall health.

  6. Patients with an eye at risk for a cornea sterile ulcer which includes:

    • Chemical injuries.
    • Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
    • History of previous sterile corneal ulceration requiring a cornea transplant.

Exclusion Criteria:

  1. Age < 18 years.
  2. Inability to provide written informed consent and comply with study assessments for the full duration of the study.
  3. Pregnant or lactating women.
  4. No or minimal tear production.
  5. Ocular or periocular malignancy.
  6. Inability to wear a contact lens due to lid abnormalities or shortened fornix.
  7. Signs of current infection, including fever and current treatment with antibiotics.
  8. Participation in another simultaneous medical investigation or trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582880

Contacts
Contact: Cornea Research 617-573-3313 cornea_research@meei.harvard.edu

Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Cornea Research     617-573-3313     cornea_research@meei.harvard.edu    
Principal Investigator: Joseph Ciolino, MD            
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Joseph Ciolino, MD Massachusetts Eye and Ear Infirmary
  More Information

No publications provided

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01582880     History of Changes
Other Study ID Numbers: 10-03-020
Study First Received: April 10, 2012
Last Updated: March 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts Eye and Ear Infirmary:
Keratoprosthesis
sterile cornea ulcer

Additional relevant MeSH terms:
Pemphigoid, Benign Mucous Membrane
Pemphigoid, Bullous
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Lupus Erythematosus, Systemic
Stevens-Johnson Syndrome
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Skin Diseases, Vesiculobullous
 Skin Diseases
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Erythema Multiforme
Erythema
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on June 17, 2013