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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL; Device: AT LISA® tri IOL

• Registration Number: NCT02691741
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-25
• Study Start: 2016-04-29
• Primary Completion: 2017-07-17
• Study Completion: 2017-07-17
• Disposition First Submitted: 2018-07-03
• Disposition First Submitted QC: 2018-07-03
• Results First Submitted: 2019-08-30
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-09-27
• Disposition First Posted: 2019-09-27
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TFNT00	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
839MP	AT LISA® tri IOL	AT LISA® tri IOL, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180	Day 120-180 from second eye implantation	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.

Secondary Outcome Measures

Name	Time	Method
Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180	Day 120-180 from second eye implantation	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.
Mean Photopic Binocular Defocus Curve at Day 120-180	Day 120-180 from second eye implantation	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.
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180	Day 120-180 from second eye implantation	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.
Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180	Day 120-180 from second eye implantation	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.
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180	Day 120-180 from second eye implantation	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.
Subject Satisfaction Recorded at Day 120-180	Day 120-180 from second eye implantation	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.
Least Squares Mean Binocular UCIVA (60cm) at Day 120-180	Day 120-180 from second eye implantation	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.
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180	Day 120-180 from second eye implantation	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.
Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180	Day 120-180 from second eye implantation	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.