NCT00932191

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

3 years

First QC Date

July 1, 2009

Last Update Submit

August 21, 2014

Conditions

Cataracts

Keywords

CataractCorneal endothelial cell lossUltrasound powerCorneal endothelium

Outcome Measures

Primary Outcomes (1)

  • Corneal endothelial cell loss by specular microscopy after cataract surgery

    3 months post-operatively

Study Arms (2)

Ultrasound phacoemulsification

ACTIVE COMPARATOR

Cataract nucleus is removed using standard amounts of ultrasound energy.

Procedure: Standard phacoemulsification

Reduced ultrasound phacoemulsification

ACTIVE COMPARATOR

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

Procedure: Reduced ultrasound phacoemulsification

Interventions

Standard phacoemulsificationPROCEDURE

Cataract nucleus removal using standard amounts of ultrasound energy

Ultrasound phacoemulsification
Reduced ultrasound phacoemulsificationPROCEDURE

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

Reduced ultrasound phacoemulsification

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visually significant moderate density cataract

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

CataractCorneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesCorneal DiseasesEye ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • David Hwang, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 3, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 25, 2014

Record last verified: 2014-08

Locations

US(1)