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Completed

NCT Number: NCT01582880

Use of Cross-linked 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).

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Key information

Conditions

Chemical Injuries Arthritis Arthritis, Rheumatoid Autoimmune Diseases Chemically-Induced Disorders Conjunctival Diseases Connective Tissue Diseases Dermatitis Drug Eruptions Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Erythema Erythema Multiforme Eye Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Mouth Diseases Musculoskeletal Diseases Ocular Cicatricial Pemphigoid Other Autoimmune Diseases Pemphigoid, Benign Mucous Membrane Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases Stevens Johnson Syndrome Stevens-Johnson Syndrome Stomatitis Stomatognathic Diseases Unspecified Complication of Corneal Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Age < 18 years.
  • Inability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Pregnant or lactating women.
  • No or minimal tear production.
  • Ocular or periocular malignancy.
  • Inability to wear a contact lens due to lid abnormalities or shortened fornix.
  • Signs of current infection, including fever and current treatment with antibiotics.
  • Participation in another simultaneous medical investigation or trial

Treatment and study plan

Riboflavin

Drug

Used to treat donor cornea before implantation

Other names: Riboflavin (vitamin B2) 0.1% solution

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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).

Sponsors and collaborators

Lead sponsor

Joseph B. Ciolino, MD

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 23, 2012
Registry last updated
Oct 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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