Visual Outcome and Visual Quality After Bilateral Implant... | NCT00760058

Studies
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL

NCT00760058

Sponsor

Alcon Research

Status

Withdrawn

Last Update Posted

May 12, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Cataract

Interventions

AcrySof® IQ IOL
Tecnis® Aspheric intraocular lens
Akreos® MI60 intraocular lens

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

Mar 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment not initiated for study.

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 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

May 8, 2015

Last Update Posted Date

May 12, 2015Estimated

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 objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.

Detailed Description

Not provided

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

Phase 4

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
1	Experimental	AcrySof® IQ intraocular lens	Device: AcrySof® IQ IOL
2	Active Comparator	Tecnis® Aspheric intraocular lens	Device: Tecnis® Aspheric intraocular lens
3	Active Comparator	Akreos® MI60 intraocular lens	Device: Akreos® MI60 intraocular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AcrySof® IQ IOL	Device	Replacement of natural crystalline lens in cataract surgery	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contrast sensitivity		3 months

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects, aged 50 and over.
Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.

Exclusion Criteria:

Subjects who have previously had corneal surgery.
Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
Subjects with corneal pathology.
Subjects with astigmatism of greater than 1D.
Subjects diagnosed with glaucoma.
Subjects diagnosed with diabetes.
Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
Subjects with a know history of poor compliance
Subjects with planned adjunctive surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases