Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal IOL.


Clinical Trial Description

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 provi de 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. Wavefront analysis is a technique currently used to measure the aberrations of the entire optical system. The term aberration derives from the Latin ab-erratio, which means going offtrack or deviating. Therefore, and aberration is the difference that exists between the ideal image of that we would expect to see when the luminous rays are refracted in the perfect optical system (Snell's law) and what is actually achieved. This technology is widely used in refractive surgery with successful outcomes. With the introduction of wavefront analysis, a new tool is available to re-design and study the performance of IOLs. Regarding IOL design, it has been used to modify the IOL to partially compensate for the average spherical aberration. The goal is to improve the ocular optical quality of pseudophakic patients. Clinical results using the aspheric monofocal IOLs confirm that this modification leads to a significant improvement, particularly in contrast sensitivity, mesopic visual quality and reduction of high order aberrations mainly spherical aberration when compare to spherical IOLs. The new aspheric ReSTOR IOL is the first single piece acrylic multifocal IOL to be available in the United States and a comparison to a regular (spherical) multifocal IOL is necessary to determine if the aspheric ReSTOR lens shows the same improvement.

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal IOL. ;


Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT00565695
Study type Observational
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date October 2007
Completion date September 2008

See also
  Status Clinical Trial Phase
Completed NCT00924729 - Study of Ocular Penetration of Topically Administered Fluoroquinolones Phase 4
Completed NCT00521456 - A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery Phase 3
Completed NCT00524264 - A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery Phase 3
Completed NCT02973880 - Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Phase 3
Completed NCT00721695 - Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification. Phase 1/Phase 2
Withdrawn NCT00466908 - Accuracy of the Pentacam and IOL Master to Calculate the Effective Corneal Power After Corneal Refractive Surgery
Completed NCT00366665 - Comparison of the Performance of the Infiniti Vision and the Series 20000 Legacy Phacoemulsification Systems N/A
Completed NCT05571683 - Cerebral Oxymeter and End Tidal Carbondioxide Values Under Surgical Drapes With and Without Past COVID-19 Infection
Not yet recruiting NCT04977115 - Clinical Evaluation of Intraocular Caliper-assisted Capsulotomy for Age-related Cataract N/A
Withdrawn NCT00366613 - Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation Phase 4
Completed NCT00366496 - Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens N/A
Not yet recruiting NCT03828500 - Preoperative Fasting for Ambulatory Cataract Surgery: The PRACTICE Study N/A
Completed NCT00840580 - Effect on Wound Healing of Vigamox Versus Cravit Phase 4
Completed NCT00842231 - Assessment of Visual Performance in Patients With Low Levels of Astigmatism N/A
Completed NCT00851760 - Epiretinal Macular Membrane and Cataract Extraction N/A
Recruiting NCT03944070 - Management of Patients With Neovascular Age-related Macular Degeneration Undergoing Cataract Surgery N/A
Completed NCT03364972 - A Study Comparing Two Monofocal, Aspheric, Hydrophobic Acrylic Intraocular Lenses: the Alcon CLAREON® and the Abbott Medical Optics PCB00 N/A
Completed NCT00824070 - Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects Phase 1
Completed NCT00366691 - Comparison of Acular LS With Lotemax to Prevent Inflammation After Cataract Surgery and Intraocular Lens Implantation Phase 4
Completed NCT00366587 - Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs Phase 4