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OpenTrials
Completed

NCT Number: NCT01988415

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustavo Tamayo, M.D.

Bogota Laser, Bogota, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSS-Rx1 OPM vs Commercial iDesign Treatment

Device

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).

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm for Wavefront-Guided Lasik Correction of Myopic Refractive Errors

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2013
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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