NCT00963742

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

August 20, 2009

Last Update Submit

March 17, 2014

Conditions

Cataract

Keywords

cataract surgeryIOLIntraocular lens

Outcome Measures

Primary Outcomes (1)

  • Distance Best Corrected Visual Acuity

    1 year

Secondary Outcomes (1)

  • FDA IOL Grid Adverse Events

    through 1 year

Study Arms (1)

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

Lenstec Softec HD IOL implantationDEVICE

surgical removal of cataract and implantation of Softec HD PCIOL

Also known as: Softec HD PCIOL, Softec HD Posterior Chamber IOL, Softec HD Posterior Chamber Intraocular Lens
Lenstec Softec HD IOL implantation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Donald R Sanders, M.D. Ph.D

    Center for Clinical Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

December 1, 2006

Primary Completion

July 1, 2009

Study Completion

April 1, 2010

Last Updated

March 18, 2014

Record last verified: 2014-03