Back to resultsFeasibility Study of the Vedera KXS for Treatment of Keratoconus
Primary Purpose
Keratoconus
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vedera KXS
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
Eligibility Criteria
Inclusion Criteria:
- 14 years of age or older
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus
- I-S ratio > 1.5 on the Pentacam map or topography map
- BSCVA worse than 20/20 (<53 letters on ETDRS chart)
- Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria:
- Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
- A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
- Corneal pachymetry <400 microns at diameter to be treated.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
- Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
Sites / Locations
- Beyoglu Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vedera KXS
Arm Description
Outcomes
Primary Outcome Measures
The reduction in Kmax (by keratometry) of >1 D
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01069848
Brief Title
Feasibility Study of the Vedera KXS for Treatment of Keratoconus
Official Title
Feasibility Study of the Vedera KXS for Treatment of Keratoconus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this investigation is to evaluate the feasibility, safety and efficacy of the Vedera KXS for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or glasses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vedera KXS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vedera KXS
Intervention Description
One treatment session with Vedera KXS
Primary Outcome Measure Information:
Title
The reduction in Kmax (by keratometry) of >1 D
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
14 years of age or older
Presence of central or inferior steepening on the Pentacam map
Axial topography consistent with keratoconus
I-S ratio > 1.5 on the Pentacam map or topography map
BSCVA worse than 20/20 (<53 letters on ETDRS chart)
Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria:
Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
Corneal pachymetry <400 microns at diameter to be treated.
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
Facility Information:
Facility Name
Beyoglu Eye Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of the Vedera KXS for Treatment of Keratoconus
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