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.

Study Overview

• Status: Terminated
• Conditions: Cataracts
• Intervention / Treatment: Procedure: Standard phacoemulsification; Procedure: Reduced ultrasound phacoemulsification

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal endothelial cell loss by specular microscopy after cataract surgery	3 months post-operatively

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: David Hwang, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 2, 2009
• First Posted (Estimate): July 3, 2009

Study Record Updates

• Last Update Posted (Estimate): August 25, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Cataract; Corneal endothelial cell loss; Ultrasound power; Corneal endothelium
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: DHCrush001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No