Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

March 17, 2014 updated by: Lenstec Incorporated

Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens

The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Barnet-Dulaney-Perkins Eye Center
    • Florida
      • Ft. Myers, Florida, United States, 33901
        • Eye Centers of Florida
    • Georgia
      • Rome, Georgia, United States, 30165
        • Harbin Clinic

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >=40 years of age, of any race and either gender
  • Operable, age related cataract grade 3+ or lower in the study eye
  • Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
  • ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
  • Able to achieve a dilated pupil >6.0 millimeter (mm) in the study eye
  • Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
  • Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
  • In good general and ocular health
  • Able to competently complete testing
  • Willing and able to attend study visits
  • Willing and able to understand and sign an informed consent

Exclusion Criteria:

  • Previous intraocular surgery or laser treatment
  • Severe dry eye
  • Uncontrolled IOP or glaucoma
  • Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
  • History of retinal detachment
  • Microphthalmia
  • Chronic severe uveitis
  • Corneal decompensation
  • Irregular astigmatism
  • History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
  • Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
  • Pseudoexfoliation syndrome
  • Iris atrophy
  • Pupil abnormalities (e.g., corectopia)
  • Aniseikonia
  • Amblyopia
  • An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
  • Pregnant, lactating, or planning to become pregnant during the course of the trial
  • Participation in another clinical trial within 30 days of study start

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Softec HD IOL
Device: Softec HD IOL
Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective Lens Position
Time Frame: 6 Months Postoperative
The position of the intraocular lens - defined by measurement of the aqueous-containing space between the corneal endothelium and the anterior surface of the intraocular lens - once implanted in the capsular bag.
6 Months Postoperative

Collaborators and Investigators

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

Sponsor

Lenstec Incorporated

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

October 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

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

  • LTHD-10-03

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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