Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens

Comparison of Visual Outcomes, Wavefront Analysis, Contrast Sensitivity and Glare Testing Following Cataract Extraction Between Acrysof Single-Piece IOL and Acrysof WF

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.

Study Overview

• Status: Completed
• Conditions: Cataract Extraction
• Intervention / Treatment: Device: Acrysof single piece (SA60AT); Device: Acrysof IQ (SN60WF)

• Study Type: Interventional
• Enrollment: 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Surgical Exclusion Criteria

• Significant anterior chamber bleeding.
• Detached Descemet's membrane
• Iris damage
• Posterior capsule rupture
• Radial tear in capsulorhexis
• Vitreous loss
• Zonular rupture.
• Use of corneal sutures for more than 1 week.

Post-implantation Exclusion Criteria

• Haptic not in the capsular bag.
• Descentration of the IOL of more than 1.0 mm
• Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Visual acuity
Contrast sensitivity

Secondary Outcome Measures

Outcome Measure
Patient satisfaction
Induction of hight order aberrations
Corneal topography

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Kerry D. Solomon, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 17, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): August 21, 2006
• Last Update Submitted That Met QC Criteria: August 17, 2006
• Last Verified: July 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: MRC-05-004