Phase 2 N=68 Randomized Double-blind Prevention

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

Keratolysis

Bottom Line

View on ClinicalTrials.gov: NCT02863809 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

May 2023

Primary outcome: Primary: Time From Surgery to Device Loss or Replacement — 95; 34 median weeks from surgery to removal

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Riboflavin (Drug); Dextran (Drug); UVA Light Source (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Joseph B. Ciolino, MD
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Surgery to Device Loss or Replacement	95; 34	—
SECONDARY Number of Participants With Kpro Retention at 12 Months	29; 27	—
SECONDARY Number of Cumulative Delayed Epithelial Healing Events at Day 30	10; 10	—
SECONDARY Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)	300.3; 253.37	—
SECONDARY Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)	188.6; 254.3	—

Summary

This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

Eligibility Criteria

Inclusion Criteria

Willing and able to provide written informed consent
Willing and able to comply with study assessments for the full duration of the study
Age ≥ 18 years
Candidate for a Boston Keratoprosthesis / Cornea transplant
In generally good stable overall health
Patients with an eye at risk for a cornea sterile ulcer which includes:
Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR
History of previous sterile cornea 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
No or minimal tear production with evidence of keratinization of the bulbar conjunctiva
Corneal or ocular surface infection within 30 days prior to study entry
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
Pregnancy (positive pregnancy test) or lactating
Participation in another simultaneous interventional medical investigation or trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02863809). 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.