Lenstec Softec HD Posterior Chamber Intraocular Lens Clinical Investigational Protocol

March 17, 2014 updated by: Lenstec Incorporated

Lenstec Softec HD Posterior Chamber Intraocular Lens (PCIOL) Clinical Investigational Protocol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenstec Softec HD IOL implantation
390 eyes of 390 study subjects all receiving the investigational IOL; IOL implanted after surgical removal of cataract
Device: Lenstec Softec HD IOL implantation
surgical removal of cataract and implantation of Softec HD PCIOL
Other Names:
  • Softec HD PCIOL
  • Softec HD Posterior Chamber IOL
  • Softec HD Posterior Chamber Intraocular Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distance Best Corrected Visual Acuity
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
FDA IOL Grid Adverse Events
Time Frame: through 1 year
through 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lenstec Incorporated

Investigators

  • Study Director: Donald R Sanders, M.D. Ph.D, Center for Clinical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE G060058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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