New Treatment Algorithm to Reduce Spherical Aberration After LASIK Correction for Myopia

This study is currently recruiting participants.
Verified November 2013 by Abbott Medical Optics
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01988415
First received: November 14, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The purpose of this clinical trial is to demonstrate that treatments generated by an investigational algorithm reduces spherical aberration compared to currently available iDesign treatments.


Condition Intervention
Myopia
Astigmatism
Device: VSS-Rx1 OPM software
Device: iDesign Advanced CustomVue wavefront-guided LASIK treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Residual uncorrected power (spherical aberration) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncorrected and best-corrected distance visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Commercial Treatment Planning Software
Approved treatment planning software
Device: iDesign Advanced CustomVue wavefront-guided LASIK treatment
Experimental: VSS-Rx1 OPM software
Investigational treatment planning software
Device: VSS-Rx1 OPM software

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female at least 18 years of age at the time of preoperative exam
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
  • Demonstration of refractive stability
  • Anticipated postoperative stromal bed thickness of at least 250 microns
  • Willing and able to return for all study examinations

Exclusion Criteria:

  • Pregnant, breast-feeding, or intend to become pregnant over the course of the study
  • Concurrent use of topical or systemic medications that may impair healing
  • History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
  • Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988415

Contacts
Contact: Eugenia Thomas, O.D. 714-247-8723 eugenia.thomas@amo.abbott.com

Locations
Colombia
Gustavo Tamayo, M.D. Recruiting
Bogota Laser, Bogota, Colombia
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Gustavo Tamayo, M.D. Medico Oftalmologo
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01988415     History of Changes
Other Study ID Numbers: STAR-114-SARA
Study First Received: November 14, 2013
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014