NCT01672814

Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

A Randomized, Controlled Study of the Vedera™ KXS Microwave System With Corneal Collagen Cross-Linking Compared With Corneal Collagen Cross-Linking Alone for Eyes With Keratoconus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cornea and Laser Eye Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure, also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in patients with keratoconus.

Detailed description

The objective of this study is to compare the safety and efficacy of the Vedera KXS (a microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in reducing corneal curvature in patients with keratoconus. Patients will be randomized into one of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave energy in an annular configuration. The goal of this procedure is to reshape the cornea to flatten the cornea and improve corneal topography in patients with keratoconus. The primary goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent progression of the disease. Moreover, investigations of crosslinking have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this study will compare the combined microwave/crosslinking treatment to crosslinking alone.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DRUG	riboflavin ophthalmic solution	Administration of riboflavin every 2 minutes for 20 minutes
DEVICE	Vedera KXS Microwave System	The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2012-08-27
• Last updated: 2018-07-17

Locations

1 site across 1 country: United States