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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248572
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : March 18, 2014
Information provided by (Responsible Party):
Lenstec Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cataract Device: Softec HD IOL Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Lens Effective Position, Stability and Prediction With a 12mm Uniplanar, Biaspheric Intraocular Lens
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248572

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

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Responsible Party: Lenstec Incorporated Identifier: NCT01248572     History of Changes
Other Study ID Numbers: LTHD-10-03
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Lenstec Incorporated:
Biaspheric intraocular lens
Uniplanar intraocular lens
Effective lens position
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases