Endothelial Cell Loss After Cataract Surgery

NCT ID: NCT00932191

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-07-31

Brief Summary

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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

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound phacoemulsification

Cataract nucleus is removed using standard amounts of ultrasound energy.

Group Type ACTIVE_COMPARATOR

Standard phacoemulsification

Intervention Type PROCEDURE

Cataract nucleus removal using standard amounts of ultrasound energy

Reduced ultrasound phacoemulsification

Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Group Type ACTIVE_COMPARATOR

Reduced ultrasound phacoemulsification

Intervention Type PROCEDURE

Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Interventions

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Standard phacoemulsification

Cataract nucleus removal using standard amounts of ultrasound energy

Intervention Type PROCEDURE

Reduced ultrasound phacoemulsification

Cataract nucleus removal using less ultrasound energy and more mechanical energy.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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DHCrush001

Identifier Type: -

Identifier Source: org_study_id

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