N/A N=26 Single-blind Treatment

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

Myopia · Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT01988415 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Mean Postoperative Spherical Aberration — 0.069; 0.016 µm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: VSS-Rx1 OPM vs Commercial iDesign Treatment (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Optics
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Postoperative Spherical Aberration	0.069; 0.016	—
PRIMARY Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity	0; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01988415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.