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Completed Phase 1Phase 2 Interventional Results available

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

ClinicalTrials.gov ID: NCT02863809

Public ClinicalTrials.gov record NCT02863809. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02863809
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Joseph B. Ciolino, MD
Other
Enrollment
76 participants

Conditions and interventions

Conditions

Interventions

Drug · Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 14, 2017
Primary completion
Jun 29, 2021
Completion
Aug 30, 2021
Last update posted
May 9, 2023

2017 – 2021

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
The Jules Stein Eye Institute Los Angeles California 90095-7003
UC Davis Health System Eye Center Sacramento California 95817
Shiley Eye Institute, University of California, San Diego San Diego California 92093
Bascom Palmer eye Institute Miami Florida 33136
Illinois Eye and Ear Infirmary Chicago Illinois 60612
Cincinnati Eye Institute Edgewood Kentucky 41017
Wilmer Eye Institute Baltimore Maryland 21287
W.K. Kellogg Eye Center Ann Arbor Michigan 48105
Tauber Eye Center Kansas City Missouri 64111
David and Ilene Flaum Eye Institute, University of Rochester New York New York 14642
University Hospitals Eye Institute Cleveland Ohio 44106
Wills Eye Bala-Cynwyd Pennsylvania 19007
Wilford Hall Ambulatory Surgical Center (WHASC) Lackland Air Force Base Texas 78236

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02863809, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 9, 2023 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02863809 live on ClinicalTrials.gov.

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