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Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite

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ClinicalTrials.gov Identifier: NCT01253239
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the visual performance of two cohorts of patients who received multifocal intraocular lenses following cataract and clear lens extraction surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom Multifocal IOL in the opposite eye.

Condition or disease
Cataract

Detailed Description:

Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and theReZoom Multifocal IOL in the opposite eye.

Study Design-A retrospective chart review to collect visual outcomes to determine lens performance. Patient satisfaction questionnaire will be administered to determine spectacle independence.


Study Design

Study Type : Observational
Actual Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Evaluation Comparing Post Operative Visual Outcomes in Patients Implanted With the TECNIS IOL in Both Eyes Versus the ReZoom IOL in One Eye and TECNIS IOL in the Opposite Eye
Study Start Date : November 2010
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
TECNIS/ReZoom
Patients who received a TECNIS multifocal IOL in one eye and a ReZoom multifocal IOL in the opposite eye.
TECNIS/TECNIS
Patients who received TECNIS multifocal IOLs in both eyes


Outcome Measures

Primary Outcome Measures :
  1. Uncorrected visual acuity at distance and near [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Patients Satisfaction [ Time Frame: Six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stable post operative cataract and clear lens extraction patients who have been implanted with either the TECNIS multifocal IOLs in both eyes or TECNIS multifocal IOL in one eye and the ReZoom in the opposite eye
Criteria

Inclusion Criteria:

  • Patients who have undergone surgery and received either the TECNIS Multifocal Intraocular lens in one eye and the ReZoom Multifocal Intraocular lens in the other will be evaluated. Males and Females with ages ranging from 42 years to 86 years old.

Exclusion Criteria:

  • Patients who have subsequently developed any visual limiting problems (e.g. corneal, retinal, infection) which could potentially limit their post operative visual potential.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01253239


Locations
United States, Pennsylvania
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Frank A. Bucci, Jr., M.D.
Investigators
Principal Investigator: Frank A Bucci, Jr., MD Bucci Laser Vision Institute
More Information

Responsible Party: Frank A. Bucci, Jr., M.D., Principal Investigator, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01253239     History of Changes
Other Study ID Numbers: TECNIS-ReZoom-2010
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute:
Visual outcomes
Patient satisfaction

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases