Feasibility Study of the Vedera KXS for Treatment of Keratoconus

Glaukos

Status: Completed

Conditions: Keratoconus

Treatments: Device: Vedera KXS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069848

Avedro T4

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 14 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Vedera KXS

Experimental group

Treatment:

Device: Vedera KXS