Endothelial Cell Loss After Cataract Surgery

This study has been terminated.
(Stopped for lack of funds)
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00932191
First received: July 1, 2009
Last updated: August 21, 2014
Last verified: August 2014
  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:


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 ]

Enrollment: 39
Study Start Date: July 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: 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: August 21, 2014
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
Capsule Opacification
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 01, 2014