Comperative Trial Between an Accommodative Iol and Monofo... | NCT00604305

Studies
Comperative Trial Between an Accommodative Iol and Monofocal Iol

NCT00604305

Sponsor

Shaare Zedek Medical Center

Status

Withdrawn

Last Update Posted

Jun 12, 2012Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

CATARACT SURGERY

Interventions

Acrysof
Acuity's AIOL

Countries

Not provided

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

ID	Type	Description	Link
Rozenman-CWPMS001

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company could not supply the accommodating intraocular lenses for the study

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jan 17, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Jan 30, 2008Estimated

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

Jun 10, 2012

Last Update Posted Date

Jun 12, 2012Estimated

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

a comparison of two intraocular lenses in regard of accommodative power.

Detailed Description

A new accommodating IOL (Acuity Ltd, Israel) will be compared with Alcon's Acrysof for 1 year for visual acuity and distance and near best corrected visual acuity.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acrysof	Active Comparator	Routine monofocal IOL	Device: Acrysof
Acuity's AIOL	Active Comparator	Accomodaing IOL	Device: Acuity's AIOL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acrysof	Device	Monofocal IOL	Acrysof
Acuity's AIOL

Measure	Description	Time Frame
distance and near visual acuity		1 year

Measure	Description	Time Frame
centration pco		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 30 and 65
Required cataract operation in one or both eyes
BCVA potetial at least 20/30
Clear intraoccular media
Willing to participate in study as evidenced by signing a written Informed Consent

Exclusion Criteria:Main

Prior surgery at the selected eye
No light perception or poor potential for improvement
Phacodonesis and damaged zonules
Pupil size at least 6 mm.
History of uveitis
Macular disease decreasing vision below 20/30
Amblyopia
Axial length shorter than 21 mm and longer than 25 mm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided