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

Cataract Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366496
• Other study ID #: MRC-05-004
• Status: Completed
• Phase: N/A
• First received: August 17, 2006
• Last updated: August 17, 2006
• Start date: July 2004
• Est. completion date: May 2005

Study information

• Verified date: July 2005
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataract Extraction

Intervention

Device:
• Acrysof single piece (SA60AT)

• Acrysof IQ (SN60WF)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast sensitivity
Primary	Visual acuity
Secondary	Induction of hight order aberrations
Secondary	Corneal topography
Secondary	Patient satisfaction