NCT02638376

Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus

A Study Evaluating the Safety and Efficacy of the KXL System With vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes Having Keratoconus and Post LASIK Ectasia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Singapore Eye Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to evaluate the safety of and efficacy of the KXL system with vibeX Rapid (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in eyes having: 1. Keratoconus (KC) , 2. Post LASIK ectasia (PLEc)

Detailed description

KC and Plec eyes Group 1 (non-randomised controlled) Eyes will be assigned into 2 groups: * Treatment eyes group with KXL * Control eyes group (fellow eye) The Treatment eyes will be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment. The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group. After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated. Group 2 (non-randomised controlled combined treatment) Eyes will be assigned into 2 groups: * Treatment group with simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK) * Control eyes group (fellow eye) The Treatment eyes will undergo simultaneous topography-guided PRK and be cross linked with the KXL system and the vibeX Rapid Riboflavin, while the control eyes will not receive any treatment. The safety and efficacy endpoints will be evaluated and compared between the Treatment eye group and the Control eye group. After 6 months of follow up the KC and PLEc subjects will be offered to treat the control eyes if indicated. The concentrations of Riboflavin Ophthalmic Solution will be tested - 0.1% Riboflavin ophthalmic solution KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off. PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous treatment or 8 minutes pulse treatment: 1 second on 1 second off..

Conditions

• Keratoconus
• Post LASIK Keratectasia

Interventions

Type	Name	Description
RADIATION	0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)	KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off. PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off.
PROCEDURE	simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)	The (Partial, Spherically Corrected) Topography-guided Transepithelial PRK Technique. Is performed with WaveLight® EX 500 excimer laser (Alcon Laboratories Inc, Ft Worth, Texas) customized platform. This software utilizes topographic data from the linked topography device (Topolyzer; Wave- Light GmbH, Erlangen, Germany). The image of the planned surgery is generated by the laser software. The topography-guided PRK is used to normalize the cornea by reducing irregular astigmatism while treating part of the refractive error. The maximum ablation depth of stromal ablation is set at 50um. A 6.5-mm, 50-μm phototherapeutic keratectomy (PTK) was performed to remove the corneal epithelium. Partial topography- guided PRK laser treatment was applied. A cellulose sponge soaked in mitomycin C (MMC) 0.02% solution was applied over the ablated tissue for 20 seconds followed by irrigation with 10 mL of chilled balanced salt solution.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2015-12-23
• Last updated: 2015-12-23

Locations

1 site across 1 country: Singapore