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
Information provided by (Responsible Party):
Abbott Medical Optics Identifier:
First received: November 14, 2013
Last updated: November 22, 2013
Last verified: November 2013

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
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


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

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 identifier: NCT01988415

Contact: Eugenia Thomas, O.D. 714-247-8723

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

No publications provided

Responsible Party: Abbott Medical Optics 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:
Refractive Errors
Eye Diseases processed this record on April 15, 2014