Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Study Overview
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Brief Summary
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The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Detailed Description
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Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Official Title
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Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof IQ PanOptix Multifocal IOL
* Device: AcrySof Monofocal IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures Clear intraocular media other than cataract in both eyes. Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes. Exclusion Criteria: Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions) Glaucoma (uncontrolled or controlled with medication) Degenerative eye disorders (e.g. macular degeneration or other retinal disorders) Pregnant or lactating Expected to require a second surgical intervention or retinal laser treatment.

Ages Eligible for Study
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Minimum Age: 22 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal IOL<br>AcrySof IQ PanOptix Multifocal IOL Model TFNT00 implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation). | Device: AcrySof IQ PanOptix Multifocal IOL<br>* AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision<br>* Other names: AcrySof® IQ PanOptix®;|
| Active Comparator: Monofocal IOL<br>AcrySof Monofocal IOL Model SN60AT implanted in the capsular bag in the posterior chamber following cataract removal and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation). | Device: AcrySof Monofocal IOL<br>* AcrySof Monofocal IOL Model SN60AT for single vision<br>* Other names: AcrySof®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m) | Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. | Month 6 (Day 120-180), post second eye implantation | 
| Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm) | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. | Month 6 (Day 120-180), post second eye implantation | 
| Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye | The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure. | Up to Month 6 (Day 120-180), post second eye implantation | 
| Mean Photopic Without Glare Binocular Distance Contrast Sensitivity | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 
| Mean Photopic With Glare Binocular Distance Contrast Sensitivity | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 
| Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 
| Mean Mesopic With Glare Binocular Distance Contrast Sensitivity | Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm) | VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye. | Month 6 (Day 120-180), post second eye implantation | 
| Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire | The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, Overall, in the past 7 days, how often did you need to wear eyeglasses to see? The proportion of subjects who respond Never is reported as a percentage calculated as (# of subjects responding Never) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100. | Month 6 (Day 120-180), post second eye implantation | 
| Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) | QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding Severe was calculated as (# of subjects responding Severe) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 
| Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID | Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding Bothered very much) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure. | Month 6 (Day 120-180), post second eye implantation | 

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