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Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

NCT02863809 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-05-10

Study results available
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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.

Conditions

  • Keratolysis

Interventions

DRUG

Riboflavin

Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.

DRUG

Dextran

Dextran is used to increase the viscosity of the solution.

DEVICE

UVA Light Source

Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Joseph B. Ciolino, MD

    lead OTHER

Principal Investigators

  • Joseph B. Ciolino, MD · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2021-06-30
Completion
2021-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02863809 on ClinicalTrials.gov