Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

NCT ID: NCT03090256

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2018-02-13

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

Detailed Description

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PanOptix IOL

AcrySof® IQ PanOptix™ IOL, bilateral implantation

Group Type: EXPERIMENTAL

AcrySof® IQ PanOptix™ IOL

Intervention Type: DEVICE

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

Interventions

AcrySof® IQ PanOptix™ IOL

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

Intervention Type: DEVICE

Other Intervention Names

Model TFNT00

Eligibility Criteria

Inclusion Criteria

• Able to comprehend and sign a statement of informed consent;
• Willing and able to complete all required postoperative visits;
• Cataracts in both eyes with planned cataract removal by phacoemulsification;
• Calculated lens power within the available range;
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
• Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion Criteria

• Significant irregular corneal aberration as demonstrated by corneal topography;
• Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
• Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
• Previous refractive surgery;
• Diabetic retinopathy
• Other eye conditions as specified in the protocol
• Pregnant.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Group Manager, Clinical Development

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

Alcon Investigative Site

Fukuoka, , Japan

Alcon Investigative Site

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ILH297-C003

Identifier Type: -

Identifier Source: org_study_id