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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366496
Other study ID # MRC-05-004
Secondary ID
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
Est. primary completion date
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


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
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