Back to resultsEndothelial Cell Loss After Cataract Surgery
Primary Purpose
Cataracts
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard phacoemulsification
Reduced ultrasound phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts focused on measuring Cataract, Corneal endothelial cell loss, Ultrasound power, Corneal endothelium
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
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ultrasound phacoemulsification
Reduced ultrasound phacoemulsification
Arm Description
Cataract nucleus is removed using standard amounts of ultrasound energy.
Cataract nucleus removal using less ultrasound energy and more mechanical energy.
Outcomes
Primary Outcome Measures
Corneal endothelial cell loss by specular microscopy after cataract surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT00932191
First Posted
July 1, 2009
Last Updated
August 21, 2014
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00932191
Brief Title
Endothelial Cell Loss After Cataract Surgery
Official Title
Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Stopped for lack of funds
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataract, Corneal endothelial cell loss, Ultrasound power, Corneal endothelium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound phacoemulsification
Arm Type
Active Comparator
Arm Description
Cataract nucleus is removed using standard amounts of ultrasound energy.
Arm Title
Reduced ultrasound phacoemulsification
Arm Type
Active Comparator
Arm Description
Cataract nucleus removal using less ultrasound energy and more mechanical energy.
Intervention Type
Procedure
Intervention Name(s)
Standard phacoemulsification
Intervention Description
Cataract nucleus removal using standard amounts of ultrasound energy
Intervention Type
Procedure
Intervention Name(s)
Reduced ultrasound phacoemulsification
Intervention Description
Cataract nucleus removal using less ultrasound energy and more mechanical energy.
Primary Outcome Measure Information:
Title
Corneal endothelial cell loss by specular microscopy after cataract surgery
Time Frame
3 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hwang, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Endothelial Cell Loss After Cataract Surgery
We'll reach out to this number within 24 hrs