NCT00366405

Brief Summary

The purpose of this study is to evaluate the visual outcomes, amount of inflammation, endothelial cell loss, and the efficiency of a torsional handpiece compared to a conventional handpiece during surgery to remove your cataracts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

Geographic Reach
1 country

1 active site

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

February 1, 2006

Completed
7 months 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
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 4, 2010

Status Verified

October 1, 2010

First QC Date

August 17, 2006

Last Update Submit

October 1, 2010

Conditions

Cataract Extraction

Keywords

cataract

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bilateral senile cataracts. Cataract density up to 3+. 50 years of age or older. Patient must desire cataract extraction. Expected maximum of 4 weeks and minimum of 1 week interval between first and second eye surgeries. Willing and able to comply with scheduled visits and other study procedures.

You may qualify if:

  • Bilateral senile cataracts.
  • Cataract density up to 3+.
  • years of age or older.
  • Patient must desire cataract extraction.
  • Expected maximum of 4 weeks and minimum of 1 week interval between first and second eye surgeries.
  • Willing and able to comply with scheduled visits and other study procedures.

You may not qualify if:

  • Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, macular edema, retinal detachment, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmus or macrophthalmus, optic nerve atrophy, macular degeneration with visual acuity of less than 20/40, glaucoma with the presence of visual field defects
  • Corneal irregularities potentially affecting visual acuity: keratoconus, corneal dystrophy, corneal opacities.
  • Low endothelial cell count (less than 1500 cells/mm2)
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye.
  • Any clinically significant, serious or severe medical or psychiatric condition.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Previous intraocular or corneal surgery.
  • Other ocular surgery at the time of the cataract extraction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Storm Eye Institute, Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Kerry D Solomon, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

February 1, 2006

Study Completion

September 1, 2007

Last Updated

October 4, 2010

Record last verified: 2010-10

Locations

US(1)