Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL
This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric Intraocular Lens (IOL)|
- Visual Acuity [ Time Frame: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery ] [ Designated as safety issue: Yes ]Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
- Spectacle Independence [ Time Frame: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery ] [ Designated as safety issue: Yes ]Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.
|Study Start Date:||November 2007|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Device: AcrySof® ReSTOR® Aspheric IOL
AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934622
|United States, Texas|
|Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|