Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

Study Overview
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Brief Summary
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The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.

Detailed Description
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The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.

Official Title
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Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models

Conditions
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Cataract

Intervention / Treatment
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* Device: ReSTOR Toric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in the eligible eye. Bilateral visually-significant cataracts Willing and able to provide written informed consent for participation in the study. Willing and able to comply with scheduled visits and other study procedures. have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) Regular corneal astigmatism of 1.00D to 2.50D in both eyes Potential postoperative acuity of 20/25 or better Exclusion Criteria: If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.) Monocular status (e.g. amblyopia) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Moderate-to-advanced glaucoma Strabismus Use of arcuate incisions for astigmatism management at the time of surgery Diabetic retinopathy Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.) History of retinal detachment Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial. The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Ages Eligible for Study
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Minimum Age: 30 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
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a prospective, single center, open clinical trial to collect normative performance data.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR Toric<br>Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. | Device: ReSTOR Toric<br>* ReSTOR Toric bilateral IOL implantation<br>* Other names: ReSTOR +3.0 Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Refractive Cylinder | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Uncorrected Near Visual Acuity | Monocular uncorrected near visual acuity measuring in logMAR | 3 months | 
| Monocular Uncorrected Distance Visual Acuity | Monocular uncorrected distance visual acuity measured in logMAR notation | 3 months | 
| Monocular Uncorrected Intermediate Visual Acuity | Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution) | 3 months | 
| Monocular Best Corrected Distance Visual Acuity | Monocular best corrected distance visual acuity measured in logMAR notation | 3 months | 
| Monocular Best Distance-corrected Intermediate Visual Acuity | Monocular best distance-corrected intermediate visual acuity in logMAR notation | 3 months | 
| Monocular Best Distance-corrected Near Visual Acuity | Monocular best distance-corrected near visual acuity measured in logMAR notation | 3 months | 
| Binocular Uncorrected Near Visual Acuity | Binocular uncorrected near (40cm) visual acuity measured in logMAR notation | 3 months | 
| Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity measured in logMAR notation | 3 months | 
| Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate (60cm) visual acuity | 3 months | 
| Binocular Best-corrected Distance Visual Acuity | Binocular best-corrected distance visual acuity measured in logMAR notation | 3 months | 
| Binocular Best Distance-corrected Intermediate Visual Acuity | Binocular best distance-corrected intermediate (60cm) visual acuity | 3 months | 
| Binocular Best Distance-corrected Near Visual Acuity | Binocular best distance-corrected near (40cm) visual acuity | 3 months | 
| IOL Orientation | Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp. | 3 months | 
| Binocular Best Distance-corrected Defocus Curve | Binocular best distance-corrected defocus curve. | 3 months | 
| Binocular Uncorrected Defocus Curve. | Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments | 3 months | 
| Subjective Visual Quality | Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and Degree of Bother aggregate statistics. Scored on a Rasch scale (0-100) where lower is better. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astigmatism, intraocular lens, multifocal