Endothelial Cell Loss After Cataract Surgery | NCT00932191

Studies
Endothelial Cell Loss After Cataract Surgery

NCT00932191

Sponsor

University of California, San Francisco

Status

Terminated

Last Update Posted

Aug 25, 2014Estimated

Enrollment

39Actual

Phase

Phase 2Phase 3

Conditions

Cataracts

Interventions

Standard phacoemulsification
Reduced ultrasound phacoemulsification

Countries

United States

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

Aug 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Stopped for lack of funds

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 1, 2009

First Submission Date that Met QC Criteria

Jul 2, 2009

First Posted Date

Jul 3, 2009Estimated

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 21, 2014

Last Update Posted Date

Aug 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare two cataract surgical technique variations for removing the nucleus of the lens (central part of the lens) in terms of damage to the inner layer of the cornea which is called the endothelium. One variation uses more ultrasound energy and the other more mechanical force to break up the nucleus.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound phacoemulsification	Active Comparator	Cataract nucleus is removed using standard amounts of ultrasound energy.	Procedure: Standard phacoemulsification
Reduced ultrasound phacoemulsification	Active Comparator	Cataract nucleus removal using less ultrasound energy and more mechanical energy.	Procedure: Reduced ultrasound phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard phacoemulsification	Procedure	Cataract nucleus removal using standard amounts of ultrasound energy	Ultrasound phacoemulsification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal endothelial cell loss by specular microscopy after cataract surgery		3 months post-operatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Visually significant moderate density cataract

Exclusion Criteria:

Corneal or retinal pathology limiting visual potential to worse than 20/40
Lens pathology including pseudoexfoliation or lens dislocation
Prior intraocular surgery
Age less than 40

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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
David Hwang, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D055954	Corneal Endothelial Cell Loss

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D003316	Corneal Diseases
D005132	Eye Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided