Comparison of the Performance of the Infiniti Vision and... | NCT00366665

Studies
Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems

NCT00366665

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Aug 21, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Cataract Extraction

Interventions

Legacy 20000
Infinit system

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

May 2005

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

Mar 2005

Primary Completion Date

Not provided

Completion Date

May 2005

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

To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ultrasound time
Amount of fluid used
Post operative visual acuity.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cataract
Eligible for cataract extraction with primary implantation of a posterior chamber IOL
2 to 3+ cataract density

Exclusion Criteria:

Preoperative ocular pathology that can affect visual acuity
Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
Previous intraocular or corneal surgery.
Other ocular surgery at the time of the cataract extraction.
Surgical Exclusion Criteria:
Significant intraoperative intraocular bleeding
Detached Descemet's membrane
Implantation of the intraocular lens in the anterior chamber or sulcus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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

Name	Type	Description	Arm Group Labels	Other Names
Legacy 20000	Device
Infinit system	Device