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

Sponsor
Glaukos Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00925041
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
26
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vedera KXS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kxl Vedera

Device: Vedera KXS
one treatment with the Vedera KXS

Outcome Measures

Primary Outcome Measures

  1. UCVA 20/40 or better [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beyoglu Eye Research and Education Hospital Istanbul Turkey

Sponsors and Collaborators

  • Glaukos Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00925041
Other Study ID Numbers:
  • Avedro T1
First Posted:
Jun 19, 2009
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Apr 26, 2021