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

NCT ID: NCT00366496

Last Updated: 2006-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-05-31

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.

Conditions

Cataract Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Acrysof single piece (SA60AT)

Intervention Type: DEVICE

Acrysof IQ (SN60WF)

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Principal Investigators

Kerry D. Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Other Identifiers

MRC-05-004

Identifier Type: -

Identifier Source: org_study_id