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

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Brief Title

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

Official Title

The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Brief Summary

      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).
    

Detailed Description

      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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Changes in Corneal Thickness at 1 Millimeter

Secondary Outcome

 Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers

Condition

Chemical Injuries

Intervention

Riboflavin

Study Arms / Comparison Groups

 Riboflavin Cross-linked donor cornea
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

March 2012

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joseph Ciolino, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01582880

Organization ID

10-03-020


Responsible Party

Sponsor-Investigator

Study Sponsor

Joseph B. Ciolino, MD


Study Sponsor

Joseph Ciolino, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary


Verification Date

October 2019