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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582880
First Posted: April 23, 2012
Last Update Posted: September 18, 2017
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.
Information provided by (Responsible Party):
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
April 10, 2012
April 23, 2012
March 21, 2017
July 24, 2017
September 18, 2017
March 2012
March 2014   (Final data collection date for primary outcome measure)
  • Changes in Corneal Thickness at 1 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
    The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
  • Changes in Corneal Thickness at 2 Millimeter [ Time Frame: measured at week 4, 6, 26, 32, 52 ]
    The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Changes in corneal thickness [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
Corneal thickness measured by OCT at 1, 3, 6, and 12 o'clock surrounding the K-Pro front plate
Complete list of historical versions of study NCT01582880 on ClinicalTrials.gov Archive Site
  • Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers [ Time Frame: post op week 52 ]
    Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.
  • Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
    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 ]
    Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
  • Lack of sterile ulcers via slit lamp [ Time Frame: post op day 1, week 1, 4, 8, 12, 16, 24, 36, 52. ]
  • Ocular Safety [ Time Frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52 ]
    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 ]
    Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Not Provided
Not Provided
 
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Used to treat donor cornea before implantation
Other Name: Riboflavin (vitamin B2) 0.1% solution
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.
Intervention: Drug: Riboflavin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01582880
10-03-020
No
Not Provided
Plan to Share IPD: No
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary
Joseph B. Ciolino, MD
Not Provided
Principal Investigator: Joseph Ciolino, MD Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP