Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-06

Study Completion Date

2016-11-22

Brief Summary

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To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

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Detailed Description

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Conditions

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Astigmatism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wave-front guided LASIK

Group Type EXPERIMENTAL

LASIK

Intervention Type DEVICE

Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System

Interventions

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LASIK

Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at lest 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria

* Women who are 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 any medical conditions that could affect wound 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 post-operative course

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes