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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Completed

CT.gov ID

NCT00366496

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Extraction	Device: Acrysof single piece (SA60AT) Device: Acrysof IQ (SN60WF)	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2004

Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Contrast sensitivity []
Visual acuity []

Secondary Outcome Measures

Induction of hight order aberrations []
Corneal topography []
Patient satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00366496

Other Study ID Numbers:

MRC-05-004

First Posted:

Aug 21, 2006

Last Update Posted:

Aug 21, 2006

Last Verified:

Jul 1, 2005

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 21, 2006