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Endothelial Cell Loss After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00932191
Recruitment Status : Terminated (Stopped for lack of funds)
First Posted : July 3, 2009
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cataracts Procedure: Standard phacoemulsification Procedure: Reduced ultrasound phacoemulsification Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique
Study Start Date : July 2009
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Corneal endothelial cell loss by specular microscopy after cataract surgery [ Time Frame: 3 months post-operatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932191


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: David Hwang, MD University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00932191     History of Changes
Other Study ID Numbers: DHCrush001
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

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

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases