Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal Intraocular Lenses (IOL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clinically evaluate the visual performance of two commercially available presbyopia-correcting Trifocal IOLs.

Detailed Description
-----------------
Subjects will attend a total of 9 visits (6 postoperative) over a 7 month period.

Official Title
-----------------
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
* Device: AT LISA® tri IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of bilateral cataracts with planned clear cornea cataract removal; Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; Calculated lens power between 13.0 and 30.0 Diopters (D); Preoperative Best-corrected distance visual acuity (BCDVA) worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in at least one eye; Potential postoperative BCDVA of 0.20 logMAR or better in both eyes. Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial; Preoperative regular corneal astigmatism of < 1.00 D, in both eyes; Clear intraocular media other than cataract in both eyes; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Reasonably expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy); Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions); Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema; Amblyopia; Previous corneal transplant; Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction; Rubella, congenital, traumatic, or complicated cataracts; Glaucoma (uncontrolled or controlled with medication); Degenerative eye disorders; History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy; Optic nerve atrophy; Expected to require retinal laser treatment; Color vision deficiencies; Pregnant or lactating (current or planned during the course of the study); Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TFNT00<br>AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation | Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL<br>* Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient<br>* Other names: Model TFNT00;|
| Active Comparator: 839MP<br>AT LISA® tri IOL, bilateral implantation | Device: AT LISA® tri IOL<br>* Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient<br>* Other names: Model 839MP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180 | VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. 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. | Day 120-180 from second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Mean Binocular UCIVA (60cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in 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. | Day 120-180 from second eye implantation | 
| Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in 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. | Day 120-180 from second eye implantation | 
| Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180 | VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in 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. | Day 120-180 from second eye implantation | 
| Mean Photopic Binocular Defocus Curve at Day 120-180 | A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed. | Day 120-180 from second eye implantation | 
| Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation | 
| Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation | 
| Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation | 
| Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180 | Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed. | Day 120-180 from second eye implantation | 
| Subject Satisfaction Recorded at Day 120-180 | At the Month 6 Visit, subjects responded to the question: Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?. Responses were reported as a percentage of subjects. No statistical test was performed. | Day 120-180 from second eye implantation |