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

NCT00925041 | Completed

• 1 other identifier: Avedro T1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• UCVA 20/40 or better

  3 months

Study Arms (1)

Kxl Vedera

EXPERIMENTAL

Device: Vedera KXS

Interventions

Vedera KXS DEVICE

one treatment with the Vedera KXS

Kxl Vedera

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glaukos Corporation: lead

Study Sites (1)

Beyoglu Eye Research and Education Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; 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: June 18, 2009
• First Posted: June 19, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

TU (1)