NCT00366665

Brief Summary

To compare the efficiency of the Infiniti vision system and the Series 20000 Legacy System phacoemulsification units during routine cataract extraction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
Last Updated

August 21, 2006

Status Verified

May 1, 2005

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (3)

  • Ultrasound time

  • Amount of fluid used

  • Post operative visual acuity.

Interventions

Legacy 20000DEVICE
Infinit systemDEVICE

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • Eligible for cataract extraction with primary implantation of a posterior chamber IOL
  • to 3+ cataract density

You may not qualify if:

  • Preoperative ocular pathology that can affect visual acuity
  • Corneal irregularities such as keratoconus, corneal dystrophy, corneal opacities.
  • Previous intraocular or corneal surgery.
  • Other ocular surgery at the time of the cataract extraction.
  • Significant intraoperative intraocular bleeding
  • Detached Descemet's membrane
  • Implantation of the intraocular lens in the anterior chamber or sulcus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kerry D. Solomon, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

March 1, 2005

Study Completion

May 1, 2005

Last Updated

August 21, 2006

Record last verified: 2005-05