Selection of Aspheric Diffractive Multifocal Intraocular... | NCT00999492

Studies
Selection of Aspheric Diffractive Multifocal Intraocular Lens (IOLS) Based on Corneal Wavefront

NCT00999492

Sponsor

Mark Packer, MD, FACS

Status

Completed

Last Update Posted

Feb 28, 2014Estimated

Enrollment

8Actual

Phase

Phase 4

Conditions

Cataracts

Interventions

Tecnis® Multifocal (TMF)

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

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

Oct 2009

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Oct 19, 2009

First Submission Date that Met QC Criteria

Oct 20, 2009

First Posted Date

Oct 21, 2009Estimated

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

Feb 26, 2014

Last Update Posted Date

Feb 28, 2014Estimated

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

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

8Actual

Name	Type	Description	Arm Group Labels	Other Names
Tecnis® Multifocal (TMF)	Device	Aspheric, diffractive multifocal intraocular lenses

Measure	Description	Time Frame
Frequency of spectacle wear		3 months postoperatively

Measure	Description	Time Frame
Frequency and degree of visual symptoms		3 months postoperatively

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Scheduled to undergo bilateral cataract or refractive lens surgery
Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
Preoperative regular corneal astigmatism of 2.5 D or less
Clear intraocular media other than cataract
Availability, willingness, and sufficient cognitive awareness to comply with examination procedures

Exclusion Criteria:

Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
Use of systemic or ocular medications that may affect visual outcomes
Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
Uncontrolled systemic or ocular disease
History of ocular trauma or prior ocular surgery
Amblyopia or strabismus
Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of worse than 20/30
Subjects who may be expected to require retinal laser treatment or other surgical intervention
Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)
Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
Requiring an intraocular lens power <15.0 or >26.0 diopters

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 4, 2014
Reset	Aug 20, 2014
Release	Aug 28, 2014
Reset	Sep 5, 2014

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 4, 2014			Aug 20, 2014
Aug 28, 2014

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases