Feasibility Study of the Vedera KXS for Treatment of Keratoconus

NCT ID: NCT01069848

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vedera KXS

Group Type: EXPERIMENTAL

Vedera KXS

Intervention Type: DEVICE

One treatment session with Vedera KXS

Interventions

Vedera KXS

One treatment session with Vedera KXS

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beyoglu Eye Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Avedro T4

Identifier Type: -

Identifier Source: org_study_id