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

NCT ID: NCT01988415

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Myopia; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: OTHER

VSS-Rx1 OPM vs Commercial iDesign Treatment

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gustavo Tamayo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medico Oftalmologo

Locations

Gustavo Tamayo, M.D.

Bogota Laser, Bogota, , Colombia

Countries

Colombia

Other Identifiers

STAR-114-SARA

Identifier Type: -

Identifier Source: org_study_id