A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

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 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Official Title
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A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1
* Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT
* Device: Acri.LISA® 366D IOL
* Device: Acri.LISA® 466TD Toric IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent; Able to attend postoperative examinations per protocol schedule; Diagnosed with bilateral cataracts; Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL); Preoperative astigmatism ≤ 2.5 diopter; Good ocular health, with the exception of cataracts; Free of disease(s)/condition(s) listed in the Caution section of the AcrySof IQ and Acri.LISA package inserts; Able to undergo second eye surgery within one month of the first eye surgery; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Previous corneal surgery; Planned multiple procedures during cataract/IOL implantation surgery; Any ocular disease and/or condition that may compromise study results; Pregnant or planning pregnancy during course of study; History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) Diabetic retinopathy; Macular degeneration; History of retinal detachment; Other protocol-defined exclusion criteria may apply.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3<br>AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1<br>* Multifocal IOL implanted for long-term use over the lifetime of the cataract patient<br>Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT<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 SND1T2, SND1T3, SND1T4, SND1T5, SND1T6;|
| Active Comparator: Acri.LISA<br>Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation | Device: Acri.LISA® 366D IOL<br>* Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient<br>Device: Acri.LISA® 466TD Toric IOL<br>* Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Binocular Defocus VA at Month 3 | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power 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 3 from second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3 | Visual acuity (VA) was tested binocularly (both eyes together) 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 3 from second eye implantation | 
| Uncorrected Visual Acuity Across a Range of Distances at Month 3 | VA was tested binocularly 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 3 from second eye implantation | 
| Mean Refractive Spherical Equivalent at Month 3 | A manifest refraction (vision check) was performed using a 100% contrast ETDRS chart under well-lit conditions. Results were documented for sphere, cylinder and axis readings. The refractive spherical equivalent was calculated according to the formula: sphere + ½ cylinder power. Both eyes contributed to the mean. | Month 3 from second eye implantation | 
| Mean Radner Reading Speed | Reading performance was measured using the Radner Reading Chart with no correction (without) and with best distance corrective aids (with). Reading speed was measured in words per minute. | Month 3 from second eye implantation | 
| Patient Reported Outcomes at Month 3 | The Visual Task Difficulty Assessment (VISTAS) questionnaire was completed by the subject to assess difficulty in completing everyday tasks that depend on good vision. Tasks were rated 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 3 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, Presbyopia, multifocal