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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01988415
First received: November 14, 2013
Last updated: January 6, 2016
Last verified: January 2016
  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 vs Commercial iDesign Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Mean Postoperative Spherical Aberration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.

  • Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]
    Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity


Enrollment: 26
Study Start Date: November 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
VSS-Rx1 OPM vs Commercial iDesign Treatment
Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
Device: VSS-Rx1 OPM vs Commercial iDesign Treatment
Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration).

Detailed Description:
Post-LASIK induction of spherical aberration is currently among the most prominent challenges for refractive surgery. The presence of significant spherical aberration in the visual system results in reduced contrast sensitivity, visual symptoms such as "glare" and "halos," and "night myopia" or the induction of myopia under low lighting (larger pupil size). A modified Treatment Planning Software (TPS) "VSS-Rx1 OPM software" has been developed that uses a modified algorithm (software that designs the LASIK treatment profile) to limit the induction of postoperative spherical aberration. Commercially available software used to calculate the LASIK treatment profile was used in one eye (active comparator [i.e., control]) and VSS-Rx1 OPM software was used in the fellow eye (experimental). Subjects were masked to the use of either the commercially available or 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988415

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

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
Results First Received: October 29, 2015
Last Updated: January 6, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astigmatism
Myopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 25, 2016