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CompletedNCT00366587Updated Jun 14, 2018

Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs

A Phase 4 interventional study of Cataract surgery and IOL implantation in Cataract Extraction, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-14.

Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cataract Extraction

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 48 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

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Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject must have an age-related cataract in both eyes.
  • 18 years of age or older.
  • Patient must desire cataract extraction.
  • Expected maximum of 4 weeks and minimum of 1 week interval between first and second eye surgeries.
  • Willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

Exclusion Criteria:

  • Preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphtalmus or macrophtalmus, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
  • Keratometric astigmatism exceeding 2.0 diopters.
  • Planned postoperative refraction for mono-vision.
  • Uncontrolled diabetes.
  • Use of any systemic or topical drug known to interfere with visual performance.
  • Contact lens use during the active treatment portion of the trial.
  • Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
  • Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
  • Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
  • Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
  • Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
  • Other ocular surgery at the time of the cataract extraction.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
48 participants

Interventions

  • DeviceCataract surgery and IOL implantation
06

Study locations

1 site
  • Storm Eye Institute, Medical University of South Carolina
    Charleston, South Carolina 29425, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00366587
Lead sponsor
Medical University of South Carolina
First posted
Aug 21, 2006
Start date
Feb 2006
Completion
Aug 2007
Last update
Jun 14, 2018

Study contacts

Kerry Solomon, MD
principal investigator · Medical University of South Carolina
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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