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

NCT01582880 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-21

Study results available
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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).

Conditions

  • Chemical Injuries
  • Unspecified Complication of Corneal Transplant
  • Autoimmune Diseases
  • Ocular Cicatricial Pemphigoid
  • Stevens Johnson Syndrome
  • Lupus Erythematosus, Systemic
  • Rheumatoid Arthritis
  • Other Autoimmune Diseases

Interventions

DRUG

Riboflavin

Used to treat donor cornea before implantation

Sponsors & Collaborators

  • Joseph B. Ciolino, MD

    lead OTHER

Principal Investigators

  • Joseph Ciolino, MD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582880 on ClinicalTrials.gov