Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs
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|ClinicalTrials.gov Identifier: NCT00366587|
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : June 14, 2018
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. Patients implanted with traditional monofocal IOLs usually require glasses for near distance tasks such as reading. The new multifocal IOLs offer the possibility of seeing well at more than one distance, without glasses or contacts.
The AcrySof ReSTOR (Alcon Laboratories) uses apodized diffractive technology — a design that responds to how wide or small the eye's pupil might be — to provide near, intermediate, and distance vision. Clinical studies used to support the March 2005 FDA approval showed that 80% of people who received the lens did not use glasses for any activities after their cataract surgery; 84% who received the lens in both eyes had distance vision of 20/25 or better, with near vision of 20/32 or better.
ReZoom (Advanced Medical Optics) is a multifocal refractive zonal IOL that distributes light over five optical zones to provide near, intermediate, and distance vision. The ReZoom is a second-generation multifocal and was FDA-approved in March 2005. In a European study of 215 patients, 93% of ReZoom recipients reported never or only occasionally needing glasses. The combined use of multifocal intraocular lenses is often a solution to best meet the patients' refractive needs. There has been speculation that the implantation of ReSTOR in one eye and ReZoom lens in the fellow eye can provide patients a larger range of useful vision in the near range.
The purpose of this study is to evaluate visual outcome and patient satisfaction after implantation of a diffractive multifocal IOL (ReSTOR) in one eye and a refractive multifocal IOL (ReZoom) in the fellow eye after routine phacoemulsification and compare it to a control group of patients implanted bilaterally with ReSTOR with both eyes targeted for 0 to ±0.25 D, and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye targeted for +1.00 D and the dominant eye targeted for 0 to +0.25 D.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Extraction||Device: Cataract surgery and IOL implantation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Contralateral Eye Comparison of Visual Outcomes and Patient Satisfaction After Routine Phacoemulsification and Implantation of ReSTOR and ReZoom IOLs|
|Study Start Date :||February 2006|
|Actual Study Completion Date :||August 2007|
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): NCT00366587
|United States, South Carolina|
|Storm Eye Institute, Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Kerry Solomon, MD||Medical University of South Carolina|