Clinical Evaluation of a 1-Piece Intraocular Lens

Study Overview
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Brief Summary
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The aims of this study are to: Demonstrate a reduction in postoperative cylinder compared to results from the control lens Demonstrate better uncorrected distance visual acuity compared to the control lens

Official Title
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Clinical Evaluation of the TECNIS® Toric 1-Piece Intraocular Lens

Conditions
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Cataract

Intervention / Treatment
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* Device: Tecnis ZCB00 IOL (control)
* Device: Toric Intraocular lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 18 years of age Cataract for which phacoemulsification extraction and posterior chamber IOL implantation has been planned for both eyes Preoperative best corrected distance visual acuity (BCDVA)of 20/40 or worse (Snellen), with or without glare, for each eye BCDVA projected to be better than 20/30 following cataract removal and IOL implantation for each eye Preoperative keratometric cylinder of 0.75 diopters to 3.62 diopters for each eye (with exception of second eyes with 0.0-0.75 diopters planned to receive non-toric IOL) Clear intraocular media other than cataract in both eyes Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits Signed informed consent and HIPAA authorization Exclusion Criteria: Requiring IOLs outside spherical power range of +15.0 to +28.0 diopters Dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)in either eye Previous corneal or intraocular surgery in either eye Irregular corneal astigmatism in either eye Corneal pathology/abnormality potentially affecting topography in either eye Corneal abnormalities such as stromal, epithelial or endothelial dystrophies in either eye Inability to achieve keratometric stability in either eye for contact lens wearers Subjects with diagnosed degenerative visual disorders in either eye(eg., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects An eccentric anterior capsulorhexis, zonular damage/rupture or capsular tear/rupture during the cataract extraction procedure Use of systemic or ocular medications that may affect vision Prior, current, or anticipated use during the course of the nine month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo)likely to affect dilation or iris structure Poorly-controlled diabetes Acute, chronic, or uncontrolled systemic disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.) Uncontrolled ocular hypertension or glaucomatous changes in the retina or visual field in either eye Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Control IOL<br>Approved Intraocular control lens | Device: Tecnis ZCB00 IOL (control)<br>* Tecnis 1-piece acrylic IOL<br>|
| Experimental: Toric IOL<br>Investigational Toric IOL | Device: Toric Intraocular lens<br>* Toric acrylic intraocular lens with various cylinder powers<br>|
| Experimental: Higher Cylinder Toric IOL<br>Investigational Toric IOLs with higher cylinder powers. | Device: Toric Intraocular lens<br>* Toric acrylic intraocular lens with various cylinder powers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Reduction in Cylinder | Reduction in cylinder postoperatively vs. preoperatively (baseline) as measured by keratometry and manifest refraction. Mean percent reduction in cylinder = (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder). Reduction in cylinder was assessed in the first eye (per participant) for contribution to the mean. | 6 months after second eye implant compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Distance Visual Acuity (UCDVA) | Postoperative uncorrected distance visual acuity as measured by LogMAR acuity. For comparison: LogMAR value of 0.0 = Snellen 20/20; LogMar 0.10 = Snellen 20/25; LogMAR 0.20 = Snellen 20/32; LogMAR 0.30 = Snellen 20/40. Uncorrected distance visual acuity as measured by LogMAR acuity was assessed in the first eye (per participant) for contribution to the mean. | 6 months after second eye implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Intraocular lens