Evaluating the Safety & Efficacy of the KXL System for Corneal Collagen

Status Recruiting

Clinical Trial 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)

Clinical Trial 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.. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02638376
Study type	Interventional
Source	Singapore Eye Research Institute
Contact	Chuan Teck Ang, Diploma
Email	ang.chuan.teck@seri.com.sg
Status	Recruiting
Phase	Phase 3
Start date	March 2013
Completion date	June 2016

View Details

See also
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Completed	`NCT01527708` - Accuracy of Curvature and Wavefront Aberrations of Posterior Corneal Surface, in Keratoconic and Post-CXL Corneas	N/A
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms