Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366587
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2006-08-17
Brief Title:
Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Contralateral Eye Comparison of Visual Outcomes and Patient Satisfaction After Routine Phacoemulsification and Implantation of ReSTOR and ReZoom IOLs
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 eyes 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 2025 or better with near vision of 2032 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 025 D and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye targeted for 100 D and the dominant eye targeted for 0 to 025 D
The AcrySof ReSTOR Alcon Laboratories uses apodized diffractive technology - a design that responds to how wide or small the eyes 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 2025 or better with near vision of 2032 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 025 D and to a group of patients implanted bilaterally with ReSTOR with the non-dominant eye targeted for 100 D and the dominant eye targeted for 0 to 025 D
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None