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

NCT ID: NCT02691741

Last Updated: 2019-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-29
• Study Completion Date: 2017-07-17

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.

Conditions

Cataracts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TFNT00

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Group Type: EXPERIMENTAL

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Intervention Type: DEVICE

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

839MP

AT LISA® tri IOL, bilateral implantation

Group Type: ACTIVE_COMPARATOR

AT LISA® tri IOL

Intervention Type: DEVICE

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Interventions

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Intervention Type: DEVICE

AT LISA® tri IOL

Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Intervention Type: DEVICE

Other Intervention Names

Model TFNT00; Model 839MP

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;

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);

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Manager, GCRA

Role: STUDY_DIRECTOR

Alcon, a Novartis Company

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

ILH297-P003

Identifier Type: -

Identifier Source: org_study_id