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

NCT01988415 | Completed Results

• 1 other identifier: STAR-114-SARA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Astigmatism

Outcome Measures

Primary Outcomes (2)

• Mean Postoperative Spherical Aberration

  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.

  3 months

• Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity

  Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity

  3 Months

Study Arms (1)

VSS-Rx1 OPM vs Commercial iDesign Treatment

OTHER

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

Interventions

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).

VSS-Rx1 OPM vs Commercial iDesign Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (1)

Gustavo Tamayo, M.D.

Bogota Laser, Bogota, Colombia

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Janice Tarrant
• Organization: Abbott Medical Optics

janice.tarrant@abbott.com

408-273-4163

Study Officials

• Gustavo Tamayo, M.D.

  Medico Oftalmologo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: November 20, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 5, 2016
• Results First Posted: February 5, 2016

Record last verified: 2016-01

Locations

CO (1)