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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: Softec HD IOL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Lens Position | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Biaspheric intraocular lens, Uniplanar intraocular lens, Effective lens position