Feasibility Study of the Vedera KXS for Treatment of Keratoconus

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.

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Device: Vedera KXS

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Beyoglu Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 14 years of age or older
2. Presence of central or inferior steepening on the Pentacam map
3. Axial topography consistent with keratoconus
4. I-S ratio > 1.5 on the Pentacam map or topography map
5. BSCVA worse than 20/20 (<53 letters on ETDRS chart)
6. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
7. Signed written informed consent
8. Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

1. Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
2. A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
3. Corneal pachymetry <400 microns at diameter to be treated.

4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

   1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
   2. 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.
5. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
6. Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
7. Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedera KXS	Device: Vedera KXS; One treatment session with Vedera KXS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The reduction in Kmax (by keratometry) of >1 D	3 months

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: Avedro T4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes