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

2014-07-23 21:08:39 | BioPortfolio

Summary

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 the steepness of the cornea in these pathologies. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.

Description

The objective of this study is to investigate the difference between the two riboflavin preparations during UV (ultraviolet) administration. Both riboflavin preparations currently are in general use worldwide and in U.S. clinical trials of corneal collagen crosslinking. The first preparation contains riboflavin in a dextran solution, which may tend to dehydrate the cornea and keep it thinner. The second preparation contains riboflavin in a solution without dextran; in this case, the relative hypotonicity may tend to keep the cornea better hydrated and thicker. The primary goal of the study is to see if the use of hypotonic riboflavin (rather than riboflavin with dextran) better maintains consistent corneal thickness during the CXL procedure. The second goal of the study is to determine if better maintenance of corneal thickness potentially could have benefits of better consistency of the procedure, decrease in corneal haze formation, and improved safety of the endothelial cells. Safety and efficacy outcomes will then be compared between the groups. In particular, we will compare the corneal thickness measured by ultrasonic pachymetry immediately after the CXL procedure in the randomized eyes. Secondary outcomes will include visual acuity, longer term corneal thickness changes, and corneal steepness changes. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Keratoconus

Intervention

Riboflavin/Dextran, Hypotonic Riboflavin

Location

Cornea and Laser Eye Institute
Teaneck
New Jersey
United States
07666

Status

Recruiting

Source

Cornea and Laser Eye Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:39-0400

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PubMed Articles [333 Associated PubMed Articles listed on BioPortfolio]

Corneal Cross-Linking: Current USA Status: Report From the Cornea Society.

The initial published clinical report on riboflavin/ultraviolet A corneal cross-linking (CXL) for treatment of progressive keratoconus dates back to 2003. CXL has since then been widely used outside t...

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...

UVA/riboflavin collagen crosslinking stiffening effects on anterior and posterior corneal flaps.

The UVA/riboflavin collagen crosslinking (CXL) is one of the treatment procedure for stopping the progression of keratoconus. The inclusion criterion for this procedure is a minimum corneal thickness ...

Validation and Development of an Escherichia coli Riboflavin Pathway Phenotypic Screen Hit as a Small-Molecule Ligand of the Flavin Mononucleotide Riboswitch.

A riboflavin biosynthesis pathway-specific phenotypic screen using a library of compounds, all with unspecified antibiotic activity, identified one small molecule later named ribocil, for which intrin...

Integrated whole-genome and transcriptome sequence analysis reveals the genetic characteristics of a riboflavin-overproducing Bacillus subtilis.

Commercial riboflavin production with Bacillus subtilis has been developed by combining rational and classical strain development for almost two decades, but how an improved riboflavin producer can be...

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)

A coenzyme for a number of oxidative enzymes including NADH DEHYDROGENASE. It is the principal form in which RIBOFLAVIN is found in cells and tissues.

A condensation product of riboflavin and adenosine diphosphate. The coenzyme of various aerobic dehydrogenases, e.g., D-amino acid oxidase and L-amino acid oxidase. (Lehninger, Principles of Biochemistry, 1982, p972)

A subset of T-lymphocytes that are present in large numbers at MUCOUS MEMBRANES and respond to INFECTIONS. They express a conserved invariant T-CELL RECEPTOR ALPHA-CHAIN that enables them to respond to infections by sensing RIBOFLAVIN metabolites of pathogens.

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