Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL... | NCT01253239

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

NCT01253239

Sponsor

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

Status

Completed

Last Update Posted

Jul 20, 2016Estimated

Enrollment

175Actual

Phase

Not provided

Conditions

Cataract

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Nov 29, 2010

First Submission Date that Met QC Criteria

Dec 2, 2010

First Posted Date

Dec 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frank A. Bucci, Jr., M.D., Principal Investigator, Bucci Laser Vision InstituteSponsor-Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

175Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Uncorrected visual acuity at distance and near		Six months

Secondary Outcomes

Measure	Description	Time Frame
Patients Satisfaction		Six months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank A Bucci, Jr., MD	Bucci Laser Vision Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bucci Laser Vision Institute		Wilkes-Barre	Pennsylvania	18702	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

Browse Leaves

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Browse Branches

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