Lenstec Softec HD Posterior Chamber Intraocular Lens Clin... | NCT00963742

Studies
Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

NCT00963742

Sponsor

Lenstec Incorporated

Status

Completed

Last Update Posted

Mar 18, 2014Estimated

Enrollment

390Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

Lenstec Softec HD IOL implantation

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

Status Module

Record Verification Date

Mar 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

Dec 2006

Primary Completion Date

Jul 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Aug 20, 2009

First Submission Date that Met QC Criteria

Aug 20, 2009

First Posted Date

Aug 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

Mar 17, 2014

Last Update Posted Date

Mar 18, 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

Description Module

Brief Summary

The objectives of this multi-center clinical investigation are to determine the safety and effectiveness of the Lenstec Softec HD Posterior Chamber intraocular lens (IOL) following one year of post-operative assessment.

Detailed Description

The Softec HD Posterior Chamber IOL is designed for the treatment of aphakia. The lens is indicated for primary implantation when a cataractous lens has been removed by phacoemulsification with circular tear capsulotomy and the posterior capsule intact. The intended benefit of the Softec HD Posterior Chamber IOL is to provide enhanced vision.

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

390Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lenstec Softec HD IOL implantation	Experimental	390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract	Device: Lenstec Softec HD IOL implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lenstec Softec HD IOL implantation	Device	surgical removal of cataract and implantation of Softec HD PCIOL	Lenstec Softec HD IOL implantation

Measure	Description	Time Frame
Distance Best Corrected Visual Acuity		1 year

Measure	Description	Time Frame
FDA IOL Grid Adverse Events		through 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cataract requiring cataract extraction
Study IOL to only be implanted in 1 eye
Distance BCVA 20/40 or worse or glare acuity worse than 20/30
Ability to comply with study follow-up requirements

Exclusion Criteria:

Patients with serious corneal disease, previous surgery or serious systemic disease
Ocular condition that could impact vision after cataract surgery
Pregnant or lactating women
Use of ocular or systemic medications that could impact vision

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald R Sanders, M.D. Ph.D	Center for Clinical Research	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided