Phase 2
Completed N=1
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
Chemical Injuries · Unspecified Complication of Corneal Transplant · autoimmune disorders · Ocular Cicatricial Pemphigoid
Source: ClinicalTrials.gov NCT01582880 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Changes in Corneal Thickness at 1 Millimeter — 730; 760; 700; 720 micrometer
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Corneal Thickness at 1 Millimeter |
730; 760; 700; 720; 680 | — |
| PRIMARY Changes in Corneal Thickness at 2 Millimeter |
940; 860; 820; 795; 780 | — |
| SECONDARY Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers |
— | — |
| SECONDARY Ocular Safety |
— | — |
| SECONDARY Systemic Safety |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01582880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.