NCT00345085

Brief Summary

This project involves evaluation of post operative contrast sensitivity and wavefront aberration results among patients implanted with standard monofocal lenses (Acrysof SN60AT/SN60WF) and the new presbyopic correcting multifocal lens (Acrysof ReSTOR). Higher Order aberrations are visual phenomena such as glare and haloes. They are more prevalent after cataract surgery and can affect night driving.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

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

March 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 25, 2014

Status Verified

June 1, 2008

First QC Date

June 23, 2006

Last Update Submit

July 24, 2014

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • post operative wavefront aberration

Secondary Outcomes (1)

  • post operative contrast sensitivity

Interventions

Wavefront and Contrast SensitivityDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTSW Medical Center at Dallas

Dallas, Texas, 75390-8866, United States

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Contrast Sensitivity

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Visual AcuityVision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological Phenomena

Study Officials

  • James P McCulley, M.D.

    UTSW Medical Center at Dallas

    STUDY CHAIR

  • Shady Awwad, M.D.

    UTSW Medical Center at Dallas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2006

First Posted

June 27, 2006

Study Start

March 1, 2005

Study Completion

April 1, 2007

Last Updated

July 25, 2014

Record last verified: 2008-06

Locations

US(1)