Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D. (TORILIOL)
The purpose of this study is to evaluate the visual outcomes and patient satisfaction after implantation of a toric IOL in patients with predicted residual corneal astigmatism between 0.75 and 1.00 D.
Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise. Over the years, the surgical technique has evolved from intracapsular extraction to modern phacoemulsification. This development has helped with the evolution of IOLs as well. The IOLs have advanced extensively: different materials and designs are available, permitting implantation through smaller, sutureless incisions. Traditional IOLs are of monofocal design providing vision at one distance, typically far; and correct mainly the spherical component of the refractive error. However, there are patients with corneal astigmatism that require additional surgical treatment such as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK) or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric IOL is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
The treatment selection of the corneal astigmatism depends on the amount of cylinder as follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between 0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Acrysof Toric SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.00 D.|
- The primary benefit from implantation of an IOL and participation in this study is the restoration of useful vision following removal of the cataracts. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: The Acrysof toric SN60T3 IOL
Multifocal Intraocular Lens
Device: The Acrysof toric SN60T3 IOL
Other Name: The Acrysof toric SN60T3 IOL
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00542581
|United States, South Carolina|
|Medical Unvirsity of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Kerry D. Solomon, MD||Storm Eye Institute|