Investigation of the Safety and Effectiveness of a Trifocal IOL

NCT ID: NCT04176965

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2024-05-13

Brief Summary

This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.

Detailed Description

The study will include adult subjects with operable cataracts in both eyes who are eligible for phacoemulsification cataract surgery followed by IOL implantation.

Conditions

Eye Diseases; Postcataract Aphakia; Cataract; Lens Opacities

Study Design

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

Study Groups

FINEVISION HP

Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.

Group Type: EXPERIMENTAL

FINEVISION HP IOL

Intervention Type: DEVICE

Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.

Control Product

Cataractous lens will be removed in the study eyes and the Alcon AcrySof® SN60AT IOL will be implanted in the capsular bag.

Group Type: ACTIVE_COMPARATOR

Alcon AcrySof SN60AT

Intervention Type: DEVICE

Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.

Interventions

FINEVISION HP IOL

Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.

Intervention Type: DEVICE

Alcon AcrySof SN60AT

Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female adults, age 22 years or older at the Preoperative Visit.

2. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery.

3. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye.

4. Projected Best Corrected Distance Visual Acuity (BCDVA) of 0.2 logMAR (20/32 Snellen) or better in each eye after cataract surgery/IOL implantation, as determined by the medical judgement of the Investigator

5. Eligible for receipt of an IOL power within the range of the investigational IOL (+10.0 D to +30.0 D, in 0.50 D increments) in each eye

6. Contact lens users must be willing to discontinue wear of their lenses in accordance with the following requirements:

• Rigid gas permeable lenses for ≥ 7 days prior to the Preoperative Visit
• Soft contact lenses for ≥ 3 days prior to the Preoperative Visit Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in each eye, as determined by manifest refraction on two consecutive examination dates at least one week apart after discontinuation of contact lens wear.

7. Provide signed written consent prior to participation in any study-related procedures.

8. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.

9. Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.

Exclusion Criteria

1. History or presence of, or predisposition to, degenerative visual disorders (e.g., macular degeneration, retinal detachment, proliferative diabetic retinopathy, or other retinal disorders) predicted to result in BCDVA worse than 0.2 LogMAR (20/32 Snellen) in either eye during the study participation period.

2. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome)

3. Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period.

4. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion.

5. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye

6. Rubella, congenital, traumatic or complicated cataract in either eye

7. Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted)

8. Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit.

9. Presence or history of one or more severe/serious ocular conditions (e.g., glaucoma, uveitis, ocular infection, severe dry eye) in either eye, or any other unstable medical condition (e.g., uncontrolled diabetes) that in the opinion of the Investigator would put the subject's health at risk, confound the results of the study and/or prevent the subject from completing all study visits.

10. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit.

11. Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.

12. Pregnant or nursing females.

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

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mitchell C Shultz MD/Shultz Chang Vision

Northridge, California, United States

Coastal Vision Medical Group

Orange, California, United States

Arbor Centers for Eye Care

Orland Park, Illinois, United States

Michael Washburn Center for Ophthalmic Research

Indianapolis, Indiana, United States

Vance Thompson Vision, MN Site

Alexandria, Minnesota, United States

Chu Vision Institute

Bloomington, Minnesota, United States

Ophthalmology Consultants, Ltd

St Louis, Missouri, United States

Vance Thompson Vision, MT Site

Bozeman, Montana, United States

Vance Thompson Vision NE Site

Omaha, Nebraska, United States

Center For Sight

Las Vegas, Nevada, United States

Eye Associates & SurgiCenter

Vineland, New Jersey, United States

Vance Thompson Vision ND Site

West Fargo, North Dakota, United States

Cleveland Eye Clinic

Brecksville, Ohio, United States

Associates in Ophthalmology Ltd

West Mifflin, Pennsylvania, United States

Vance Thompson Vision. SD Site

Sioux Falls, South Dakota, United States

Key-Whitman Eye Center

Dallas, Texas, United States

Lehmann Eye Center

Nacogdoches, Texas, United States

Parkhurst Nuvision

San Antonio, Texas, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PHY1903

Identifier Type: -

Identifier Source: org_study_id