Evaluation of Outcomes Following LASIK Surgery Using Cust... | NCT00366769

Studies
Evaluation of Outcomes Following LASIK Surgery Using CustomVue

NCT00366769

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Aug 21, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Myopia
Astigmatism
Myopic Astigmatism

Interventions

Wavefront-guided LASIK using CustomVue platform

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Aug 17, 2006

First Submission Date that Met QC Criteria

Aug 17, 2006

First Posted Date

Aug 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2006

Last Update Posted Date

Aug 21, 2006Estimated

Description Module

Brief Summary

The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Wavefront-guided LASIK using CustomVue platform	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity
Induction of high order aberrations

Secondary Outcomes

Measure	Description	Time Frame
Contrast sensitivity & glare
Patient satisfaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopia 0.00 to -6.00 D
Astigmatism 0.00 up to -3.00 D
Manifest refraction spherical equivalent (MRSE) up to -6.00 D.

Exclusion Criteria:

History of ocular pathology
Previous ocular surgery
Large pupils (greater than 8mm diameter, infrared measurement)
Thin corneas (preoperatively calculated minimal residual bed < 250 um)
Irregular astigmatism
Asymmetric astigmatism
Unstable refraction
Any other condition that precludes the patient from undergoing LASIK

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kerry D. Solomon, MD	Medical University of South Carolina	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia
D001251	Astigmatism

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided