Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

NCT ID: NCT00963742

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lenstec Softec HD IOL implantation

390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract

Group Type EXPERIMENTAL

Lenstec Softec HD IOL implantation

Intervention Type DEVICE

surgical removal of cataract and implantation of Softec HD PCIOL

Interventions

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Lenstec Softec HD IOL implantation

surgical removal of cataract and implantation of Softec HD PCIOL

Intervention Type DEVICE

Other Intervention Names

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Softec HD PCIOL Softec HD Posterior Chamber IOL Softec HD Posterior Chamber Intraocular Lens

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lenstec Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald R Sanders, M.D. Ph.D

Role: STUDY_DIRECTOR

Center for Clinical Research

Other Identifiers

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IDE G060058

Identifier Type: -

Identifier Source: org_study_id

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