NCT00366496

Brief Summary

To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.

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 Jul 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
10 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

July 1, 2005

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

Cataract Extraction

Outcome Measures

Primary Outcomes (2)

  • Contrast sensitivity

  • Visual acuity

Secondary Outcomes (3)

  • Induction of hight order aberrations

  • Corneal topography

  • Patient satisfaction

Interventions

Acrysof single piece (SA60AT)DEVICE
Acrysof IQ (SN60WF)DEVICE

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral or bilateral cataract
  • Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
  • Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
  • Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
  • Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.

You may not qualify if:

  • Preoperative ocular pathology potentially affecting visual acuity
  • Previous intraocular or corneal surgery.
  • Keratometric astigmatism exceeding 1.5 diopters.
  • Planned postoperative refraction for mono-vision.
  • Current contact lens usage.
  • Other ocular surgery at the time of the cataract extraction.
  • Uncontrolled diabetes.
  • Any neurological condition that might interfere with performance of required test.
  • Auto-immune deficiency disease.
  • Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Significant anterior chamber bleeding.
  • Detached Descemet's membrane
  • Iris damage
  • Posterior capsule rupture
  • +7 more criteria

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

July 1, 2004

Study Completion

May 1, 2005

Last Updated

August 21, 2006

Record last verified: 2005-07