Status:
COMPLETED
Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens
Lead Sponsor:
Medical University of South Carolina
Conditions:
Cataract Extraction
Eligibility:
All Genders
50-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00366496
Start Date
July 1 2004
End Date
May 1 2005
Last Update
August 21 2006
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