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

Alcon Research0 sites215 target enrollmentApril 29, 2016

ConditionsCataracts

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataracts
Sponsor: Alcon Research
Enrollment: 215
Primary Endpoint: Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 29, 2016

End Date

July 17, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180

Time Frame: 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 Outcomes

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