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Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs
NCT00366587 · View on ClinicalTrials.gov ↗
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 m
Conditions Studied
Interventions
- DEVICE Cataract surgery and IOL implantation
Study Locations (1)
South Carolina
- Storm Eye Institute, Medical University of South Carolina — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2006-02 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00366587
The ClinicalTrials.gov registry entry for NCT00366587 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cataract Extraction appearing as the primary indexed condition, and to 1 intervention — of which Cataract surgery and IOL implantation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00366587 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00366587 about?
NCT00366587 is a clinical study titled "Comparison of Visual Outcomes and Patient Satisfaction After Cataract Surgery and Implantation of ReSTOR and ReZoom IOLs". 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 th...
What is the current status of trial NCT00366587?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2006-02. Estimated completion is 2007-08.
What conditions does trial NCT00366587 study?
This clinical trial studies the following conditions: Cataract Extraction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00366587?
The interventions under investigation include: Cataract surgery and IOL implantation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00366587?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00366587 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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