Endothelial Cell Loss After Cataract Surgery

Phase 2

Terminated

• Conditions: Cataracts
• Interventions: Procedure: Standard phacoemulsification; Procedure: Reduced ultrasound phacoemulsification

• Registration Number: NCT00932191
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Visually significant moderate density cataract

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound phacoemulsification	Standard phacoemulsification	Cataract nucleus is removed using standard amounts of ultrasound energy.
Reduced ultrasound phacoemulsification	Reduced ultrasound phacoemulsification	Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Primary Outcome Measures

Name	Time	Method
Corneal endothelial cell loss by specular microscopy after cataract surgery	3 months post-operatively

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States