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

July 1, 2009
April 7, 2011
July 2009
July 2011   (final data collection date for primary outcome measure)
Corneal endothelial cell loss by specular microscopy after cataract surgery [ Time Frame: 3 months post-operatively ] [ Designated as safety issue: Yes ]
Corneal endothelial cell loss by specular microscopy after cataract surgery [ Time Frame: 1 month and 3 months post-operatively ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00932191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endothelial Cell Loss After Cataract Surgery
Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cataracts
  • Procedure: Standard phacoemulsification
    Cataract nucleus removal using standard amounts of ultrasound energy
  • Procedure: Reduced ultrasound phacoemulsification
    Cataract nucleus removal using less ultrasound energy and more mechanical energy.
  • Active Comparator: Ultrasound phacoemulsification
    Cataract nucleus is removed using standard amounts of ultrasound energy.
    Intervention: Procedure: Standard phacoemulsification
  • Active Comparator: Reduced ultrasound phacoemulsification
    Cataract nucleus removal using less ultrasound energy and more mechanical energy.
    Intervention: Procedure: Reduced ultrasound phacoemulsification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact: David Hwang, MD 415 476-7977 David.Hwang@ucsf.edu
Contact: Jennifer Taylor, MD 415-476-1922 TaylorJB@vision.ucsf.edu
United States
 
NCT00932191
DHCrush001
No
David Hwang/Professor of Ophthalmology and Director of the Cornea and Refractive Surgery Service, University of California - San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: David Hwang, MD University of California, San Francisco
University of California, San Francisco
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP