Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia

The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Beyoglu Eye Research and Education Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must be undergoing surgery for the correction of myopia
• Intended treatment from -0.5 to -6.0 D of spherical myopia
• Must have 0.50 D or less astigmatic component.
• Must have bilateral physiologic myopia
• BSCVA of 20/25 or better in each eye
• Must have had a stable refraction (0.5 D or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old)
• Patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation
• Must be at least 18 years of age
• Corneal topography must be normal, as judged by the investigator
• Must have a minimal corneal thickness of 475 microns
• Must sign a written Informed Consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for Informed Consent practices
• Must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment

Exclusion Criteria:

• Patients who are unable or unwilling to sign the informed consent form.
• Anterior segment pathology
• Residual, recurrent or active ocular disease
• Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
• History of herpes keratitis
• Patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing.
• Irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus.
• Patients with known sensitivity to study medications.
• Intraocular pressure of > 23 mm Hg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect.
• Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
• Participation in other ophthalmic clinical trials during this clinical 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: Kxl Vedera	Device: Vedera KXS; one treatment with the Vedera KXS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
UCVA 20/40 or better	3 months

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 18, 2009
• First Submitted That Met QC Criteria: June 18, 2009
• First Posted (Estimate): June 19, 2009

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; Refractive Errors; Myopia
• Other Study ID Numbers: Avedro T1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No