Visual and Refractive Outcomes After Implantation of Aspheric IOLs With Different Dioptric Increments and Manufacturing

Study Overview
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Brief Summary
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This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.

Official Title
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A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery

Conditions
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Cataract

Intervention / Treatment
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* Device: Intraocular Lens (IOL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: operable cataracts in both eyes require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes </=1 diopter (D) of regular astigmatism in both eyes Exclusion Criteria: Intraocular surgery or laser treatment prior to cataract surgery Severe dry eye Presence of ocular infection Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better History of retinal detachment Corneal decompensation History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy) Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tecnis Z9002 Intraocular Lens (IOL)<br> | Device: Intraocular Lens (IOL)<br>* Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.<br>|
| Active Comparator: Softec HD Intraocular Lens (IOL)<br> | Device: Intraocular Lens (IOL)<br>* Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target versus Achieved Refraction |  | 3 Months Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity |  | 3 Months Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens (IOL), Quarter Diopter, Biaspheric