Ignite Creation Date:
2025-12-18 @ 8:52 AM
Ignite Modification Date:
2025-12-18 @ 8:52 AM
Study NCT ID:
NCT02638376
Status:
None
Last Update Posted:
2015-12-23 00:00:00
First Post:
2014-09-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus
Sponsor:
None
Organization:
Study Overview
Official Title:
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:
None
Status Verified Date:
2015-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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..
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..
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: