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

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Cataract Extraction

Treatments

Device: Acrysof IQ (SN60WF)

Device: Acrysof single piece (SA60AT)

Study type

Interventional

Funder types

Other

Identifiers

NCT00366496

MRC-05-004

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 80 years old

Volunteers

No 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.