NCT01253239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

4.7 years

First QC Date

November 29, 2010

Last Update Submit

July 18, 2016

Conditions

Keywords

Visual outcomesPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Uncorrected visual acuity at distance and near

    Six months

Secondary Outcomes (1)

  • Patients Satisfaction

    Six months

Study Arms (2)

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

Eligibility Criteria

Age42 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

CataractPatient Satisfaction

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Frank A Bucci, Jr., MD

    Bucci Laser Vision Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations