Completed

NCT Number: NCT02863809

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Keratolysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Jules Stein Eye Institute, Los Angeles, California, United States

About this study

The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.

CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riboflavin

Drug

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

Other names: Vitamin B2

Dextran

Drug

Dextran is used to increase the viscosity of the solution.

Other names: Dextran 70 6% in 0.9%, Sodium Chloride Dextran 70 6% in 5% Dextrose, Gentran 70, Hyskon

UVA Light Source

Device

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.

Other names: KXL® System

Primary outcomes

Time From Surgery to Device Loss or Replacement

Time frame: 2 years

If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.

Secondary outcomes

Number of Participants With Kpro Retention at 12 Months

Time frame: Twelve months

The number of participants that retained kpro devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported
Number of Cumulative Delayed Epithelial Healing Events at Day 30

Time frame: 30 days

The number of incidences of delayed epithelial healing at day 30 will be recorded. If there is delayed epithelial healing at day 30 it will be determined if those incidences occurred more often in the control group versus the investigational group.
Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)

Time frame: 2 years

If follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and the number of incidences will be compared between the study treatment groups
Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)

Time frame: 2 years

The time (days) and number of incidences of vitritis will be recorded for the subject in which it occurred and the number of incidences will be compared between the study treatment groups.

Sponsors and collaborators

Lead sponsor

Joseph B. Ciolino, MD

Other

Collaborators

United States Department of Defense

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Aug 11, 2016
Registry last updated: May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.