Endothelial Cell Loss After Cataract Surgery

Cataracts Clinical Trial

Official title:

Endothelial Cell Loss After Cataract Surgery: Comparison of a Reduced Ultrasound Technique Versus Standard Ultrasound Technique

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00932191
• Other study ID #: DHCrush001
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 1, 2009
• Last updated: August 21, 2014
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cataracts

Intervention

Procedure:
• Standard phacoemulsification
Cataract nucleus removal using standard amounts of ultrasound energy
• Reduced ultrasound phacoemulsification
Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal endothelial cell loss by specular microscopy after cataract surgery		3 months post-operatively	Yes