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Endothelial Cell Loss After Cataract Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of California, San Francisco.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00932191
First received: July 1, 2009
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cataracts
 Procedure: Standard phacoemulsification
Procedure: Reduced ultrasound phacoemulsification
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Corneal endothelial cell loss by specular microscopy after cataract surgery [ Time Frame: 3 months post-operatively ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ultrasound phacoemulsification
Cataract nucleus is removed using standard amounts of ultrasound energy.
 Procedure: Standard phacoemulsification
Cataract nucleus removal using standard amounts of ultrasound energy
Active Comparator: Reduced ultrasound phacoemulsification
Cataract nucleus removal using less ultrasound energy and more mechanical energy.
 Procedure: Reduced ultrasound phacoemulsification
Cataract nucleus removal using less ultrasound energy and more mechanical energy.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932191

Contacts
Contact: David Hwang, MD 415 476-7977 David.Hwang@ucsf.edu
Contact: Jennifer Taylor, MD 415-476-1922 TaylorJB@vision.ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: David Hwang, MD     415-476-7977     David.Hwang@ucsf.edu    
Principal Investigator: David Hwang, MD            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: David Hwang, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: David Hwang/Professor of Ophthalmology and Director of the Cornea and Refractive Surgery Service, University of California - San Francisco
ClinicalTrials.gov Identifier: NCT00932191     History of Changes
Other Study ID Numbers: DHCrush001
Study First Received: July 1, 2009
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Cataract
Corneal endothelial cell loss
Ultrasound power
Corneal endothelium

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013