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Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

2016-08-12 08:53:21 | BioPortfolio

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.

Description

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.

Tissue Bank International (Orlando site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at Tissue Bank International will 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Keratolysis

Intervention

Riboflavin, Dextran, UVA Light Source

Location

The Jules Stein Eye Institute
LA
California
United States
90095-7003

Status

Not yet recruiting

Source

Massachusetts Eye and Ear Infirmary

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-12T08:53:21-0400

Clinical Trials [580 Associated Clinical Trials listed on BioPortfolio]

Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing t...

Accelerated Corneal Cross-linking With Different Riboflavin Solutions

Following the Bunsen-Roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. In addition, new riboflavin sol...

Corneal Collagen Cross-Linking for Ectasia (CXL)

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia a...

Effects of Riboflavin on Faecalibacterium Prausnitzii and the Gut Microbiota

The purpose of this trial is to investigate comprehensively the effect of riboflavin supplementation on the abundance of F. prausnitzii and on other members of the gut microbiota in faeces...

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PubMed Articles [8124 Associated PubMed Articles listed on BioPortfolio]

Light exposure during growth increases riboflavin production, ROS accumulation and DNA damage in Ashbya gossypii riboflavin-overproducing strains.

The overproduction of riboflavin (vitamin B2) by Ashbya gossypii, one of the most distinctive traits of this filamentous hemiascomycete, has been proposed to act as an ecological defense mechanism, si...

Rose Bengal and Green Light Versus Riboflavin-UVA Cross-Linking: Corneal Wound Repair Response.

To study corneal wound healing after two cross-linking techniques using either rose bengal and green light (RGX) or the conventional treatment using riboflavin and UVA radiation (UVX).

Chemiluminescence of Lucigenin/Riboflavin and Its Application for Selective and Sensitive Dopamine Detection.

Lucigenin-riboflavin chemiluminescence is reported for the first time. Moreover, most dopamine chemiluminescence (CL) detection methods are based on the quenching of CL by dopamine. In contrast, we fi...

Fabrication of resveratrol-loaded whey protein-dextran colloidal complex for the stabilization and delivery of β-carotene emulsions.

The effects of resveratrol (RES)-loaded whey protein isolate (WPI)-dextran nanocomplex on the physicochemical stability of β-carotene (BC) emulsions were evaluated. WPI-dextran was prepared by Mailla...

A novel LC-MS/MS assay for vitamin B, B and B determination in dried blood spots and its application in children.

Thiamin, riboflavin and pyridoxal phosphate (PLP) concentrations are useful indices for evaluating vitamin B, B and B status. Several HPLC assays have been developed for determining thiamin, riboflavi...

Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the formation of riboflavin from two molecules of 6,7-dimethyl-8-ribityllumazine, utilizing a four-carbon fragment from one molecule which is transferred to the second molecule. EC 2.5.1.9.

A dietary deficiency of riboflavin causing a syndrome chiefly marked by cheilitis, angular stomatitis, glossitis associated with a purplish red or magenta-colored tongue that may show fissures, corneal vascularization, dyssebacia, and anemia. (Dorland, 27th ed)

Nutritional factor found in milk, eggs, malted barley, liver, kidney, heart, and leafy vegetables. The richest natural source is yeast. It occurs in the free form only in the retina of the eye, in whey, and in urine; its principal forms in tissues and cells are as FLAVIN MONONUCLEOTIDE and FLAVIN-ADENINE DINUCLEOTIDE.

An optical source that emits photons in a coherent beam. Light Amplification by Stimulated Emission of Radiation (LASER) is brought about using devices that transform light of varying frequencies into a single intense, nearly nondivergent beam of monochromatic radiation. Lasers operate in the infrared, visible, ultraviolet, or X-ray regions of the spectrum.

A behavioral change that results in an organism moving or orienting toward or away from the light source.

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