An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation Following Intraocular Lens (IOL) Implantation
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|ClinicalTrials.gov Identifier: NCT01190631|
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : November 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cataracts||Device: Acrysof IQ (SN60WF) IOL||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||An Assessment of Residual Spherical Aberration, Postoperative Total High Order Aberrations, and Functional Vision Correlation After SN60WF IOL Implantation|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2011|
Experimental: Acrysof IQ (SN60WF) IOL
AcrySof IQ SN60WF intraocular lens (IOL) implanted in one eye only during cataract surgery.
Device: Acrysof IQ (SN60WF) IOL
Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.
Other Name: Acrysof® IQ Model SN60WF
- Contrast Sensitivity [ Time Frame: Day 90 postoperative ]Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
- Total Higher Order Aberrations [ Time Frame: Day 90 postoperative ]A higher order aberration is a distortion acquired by a wavefront light when it passes through an eye with irregularities of its refractive components (tear film, cornea, aqueous humor, crystalline lens and vitreous humor). It is measured via wavefront measurements according to manufacturer's instructions with a LADARWave (Alcon Laboratories, Inc., Ft. Worth TX).
- Corneal Spherical Aberration [ Time Frame: Day 90 postoperative ]Corneal spherical aberration is the blurring of an image that occurs when light from the margin of a lens or mirror with a spherical surface comes to a shorter focus than light from the central portion. The changing focal length is caused by deviations in the lens or mirror surface from a true sphere and is measured by corneal topography with a commercially available topographer in accordance with manufacturer's guidelines.
- Uncorrected Visual Acuity (UCVA) [ Time Frame: Day 90 postoperative ]Uncorrected visual acuity, i.e., visual acuity without any type of corrective lenses, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
- Best Corrected Visual Acuity (BCVA) [ Time Frame: Day 90 postoperative ]Best corrected visual acuity, i.e., visual correction utilizing a phoropter or trial frames, is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
- Low Contrast (10%) Visual Acuity [ Time Frame: Day 90 postoperative ]Visual acuity is tested using 10% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts under photopic conditions. Testing is performed using the correction from the manifest refraction at a distance calibrated for the chart. Visual acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution," and a lower logMAR value indicates better visual acuity.
- Quality of Vision Questionnaire [ Time Frame: Day 90 postoperative ]As completed by the participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190631
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|