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

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 Ultrasound

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 ]


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 (Adult, Senior)
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


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 September 29, 2016

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