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

Glaukos

Status

Completed

Conditions

Myopia

Treatments

Device: Vedera KXS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00925041

Avedro T1

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.