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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01988415
Recruitment Status : Completed
First Posted : November 20, 2013
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Astigmatism Device: VSS-Rx1 OPM vs Commercial iDesign Treatment Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Mean Postoperative Spherical Aberration [ Time Frame: 3 months ]
    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.

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988415


Locations
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Colombia
Gustavo Tamayo, M.D.
Bogota Laser, Bogota, Colombia
Sponsors and Collaborators
Abbott Medical Optics
Investigators
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Principal Investigator: Gustavo Tamayo, M.D. Medico Oftalmologo
More Information
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01988415    
Other Study ID Numbers: STAR-114-SARA
First Posted: November 20, 2013    Key Record Dates
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Myopia
Astigmatism
Refractive Errors
Eye Diseases