Feasibility Study of the Vedera KXS for Treatment of Keratoconus

NCT01069848 | Completed FDA Device

• 1 other identifier: Avedro T4
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• The reduction in Kmax (by keratometry) of >1 D

  3 months

Study Arms (1)

Vedera KXS

EXPERIMENTAL

Device: Vedera KXS

Interventions

Vedera KXS DEVICE

One treatment session with Vedera KXS

Vedera KXS

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Beyoglu Eye Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

TU (1)