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NCT Number: NCT01248572

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Barnet-Dulaney-Perkins Eye Center, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Softec HD IOL

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Lenstec Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2010
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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