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

NCT ID: NCT01253239

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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TECNIS/ReZoom

Patients who received a TECNIS multifocal IOL in one eye and a ReZoom multifocal IOL in the opposite eye.

No interventions assigned to this group

TECNIS/TECNIS

Patients who received TECNIS multifocal IOLs in both eyes

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

42 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Frank A. Bucci, Jr., M.D.

OTHER

Sponsor Role lead

Responsible Party

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Frank A. Bucci, Jr., M.D.

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frank A Bucci, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute

Locations

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Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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TECNIS-ReZoom-2010

Identifier Type: -

Identifier Source: org_study_id

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