Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

Study Overview
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Brief Summary
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The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.

Detailed Description
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Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.

Official Title
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A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent; Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes; Able to undergo second eye surgery within one month (30 days) of first eye surgery; Able to attend postoperative examinations per protocol schedule; Qualify for a AcrySof IQ Toric IOL in both eyes; Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes; Residual refractive cylinder of ≤0.5 D in both eyes; Good ocular health; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Planned multiple procedures, including LRI, during cataract/IOL implantation surgery; Amblyopia; Previous corneal surgery; Clinically significant corneal endothelial dystrophy; History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.); History of retinal detachment; Pregnant or planning to become pregnant during course of study; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3.0<br>AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL<br>* Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient<br>* Other names: Models SND1T3, SND1T4, SND1T5;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuity Across a Range of Distances at Month 6 | Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. | Month 6 from second eye implantation | 
| Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6 | VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. | Month 6 from second eye implantation | 
| Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6 | Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects. | Month 6 from second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes at Month 6 | The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Distance specific tasks were rated (without / with corrective aids) using a 1 to 5 point scale, where 1 = no difficulty; 2 = minor difficulty; 3 = moderate difficulty; 4 = major difficulty; 5 = cannot accomplish. Individual scores for each task were averaged to obtain the overall score for each vision type/function. Near vision was defined as less than 50 cm; intermediate vision as 50 cm to 1 m; extended intermediate vision as 90 cm to 4 m; and distant vision as more than 4 m. | Month 6 from second eye implantation | 

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