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Investigation of the Safety and Effectiveness of a Trifocal IOL

Primary Purpose

Eye Diseases, Postcataract Aphakia, Cataract

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FINEVISION HP IOL
Alcon AcrySof SN60AT
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Diseases focused on measuring Intraocular Lens, Multifocal, Hydrophobic

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female adults, age 22 years or older at the Preoperative Visit. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye. Projected 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 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 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. Provide signed written consent prior to participation in any study-related procedures. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. 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: 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. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye Rubella, congenital, traumatic or complicated cataract in either eye Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted) Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit. 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. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit. 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. Pregnant or nursing females.

Sites / Locations

  • Mitchell C Shultz MD/Shultz Chang Vision
  • Coastal Vision Medical Group
  • Arbor Centers for Eye Care
  • Michael Washburn Center for Ophthalmic Research
  • Vance Thompson Vision, MN Site
  • Chu Vision Institute
  • Ophthalmology Consultants, Ltd
  • Vance Thompson Vision, MT Site
  • Vance Thompson Vision NE Site
  • Center For Sight
  • Eye Associates & SurgiCenter
  • Vance Thompson Vision ND Site
  • Cleveland Eye Clinic
  • Associates in Ophthalmology Ltd
  • Vance Thompson Vision. SD Site
  • Key-Whitman Eye Center
  • Lehmann Eye Center
  • Parkhurst Nuvision
  • The Eye Institute of Utah
  • Piedmont Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FINEVISION HP

Control Product

Arm Description

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

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

Outcomes

Primary Outcome Measures

Corrected distance visual acuity (BCDVA) in first operative eyes
Photopic monocular logMAR best corrected distance visual acuity (BCDVA) in first operative eyes at Month 6 (Visit 4)
Distance corrected Near visual acuity (DCNVA) in first operative eyes
Photopic monocular logMAR distance corrected near visual acuity (DCNVA) in first operative eyes at Month 6 (Visit 4)

Secondary Outcome Measures

Distance corrected Intermediate visual acuity at 66 cm in first operative eyes
Mean photopic monocular DCVA at intermediate (66 cm) for the first operative eye at Month 6

Full Information

First Posted
November 20, 2019
Last Updated
September 5, 2023
Sponsor
Beaver-Visitec International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04176965
Brief Title
Investigation of the Safety and Effectiveness of a Trifocal IOL
Official Title
Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
November 9, 2023 (Anticipated)
Study Completion Date
November 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Postcataract Aphakia, Cataract, Lens Opacities
Keywords
Intraocular Lens, Multifocal, Hydrophobic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Approximately 501 subjects will be screened across up to 24 study sites to complete 300 subjects implanted bilaterally with the FINEVISION HP and 150 subjects implanted bilaterally with the control monofocal Alcon AcrySof SN60AT.
Masking
ParticipantOutcomes Assessor
Masking Description
In order to minimize bias, site personnel performing postoperative study assessments of visual performance will be masked to subject treatment assignment until after the final database lock ("masked assessors").
Allocation
Randomized
Enrollment
501 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FINEVISION HP
Arm Type
Experimental
Arm Description
Trifocal FINEVISION HP. Cataractous lens will be removed in the study eyes and the FINEVISION HP will be implanted in the capsular bag.
Arm Title
Control Product
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
FINEVISION HP IOL
Intervention Description
Cataractous lens will be removed in the study eyes and the FINEVISION HP IOL will be implanted in the capsular bag.
Intervention Type
Device
Intervention Name(s)
Alcon AcrySof SN60AT
Intervention Description
Cataractous lens will be removed in the study eyes and the Alcon AcrySof SN60AT IOL will be implanted in the capsular bag.
Primary Outcome Measure Information:
Title
Corrected distance visual acuity (BCDVA) in first operative eyes
Description
Photopic monocular logMAR best corrected distance visual acuity (BCDVA) in first operative eyes at Month 6 (Visit 4)
Time Frame
150-180 days after surgery on the first eye
Title
Distance corrected Near visual acuity (DCNVA) in first operative eyes
Description
Photopic monocular logMAR distance corrected near visual acuity (DCNVA) in first operative eyes at Month 6 (Visit 4)
Time Frame
150-180 days after surgery on the first eye
Secondary Outcome Measure Information:
Title
Distance corrected Intermediate visual acuity at 66 cm in first operative eyes
Description
Mean photopic monocular DCVA at intermediate (66 cm) for the first operative eye at Month 6
Time Frame
150-180 days after surgery on the first eye

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female adults, age 22 years or older at the Preoperative Visit. Visually significant cataracts in both eyes that are eligible for phacoemulsification cataract surgery. Willing to undergo cataract surgery in the second operative eye within 7 - 30 days after surgery in the first eye. Projected 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 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 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. Provide signed written consent prior to participation in any study-related procedures. Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits. 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: 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. Significant anterior segment pathology in either eye that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome) Reasonably expected to require secondary ocular surgical intervention or laser treatment other than YAG capsulotomy in either eye during the study participation period. Presence of one or more clinically significant corneal abnormalities in either eye, including corneal dystrophy, irregularity, or edema per the Investigator's medical opinion. Previous intraocular, corneal, or retinal detachment surgery, including corneal transplant, LASIK, astigmatic keratotomy and limbal relaxing incisions in either eye Rubella, congenital, traumatic or complicated cataract in either eye Preoperative keratometric astigmatism > 1.0 D or irregular corneal astigmatism in either eye (Note: corneal incisions intended to reduce astigmatism are not permitted) Clinically significant ocular inflammation or infection present ≤ 30 days in either eye prior to the Preoperative Visit. 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. Use of medications known to interfere with visual performance, pupil dilation, or iris structure ≤ 30 days prior to the Preoperative Visit. 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. Pregnant or nursing females.
Facility Information:
Facility Name
Mitchell C Shultz MD/Shultz Chang Vision
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Coastal Vision Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Arbor Centers for Eye Care
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Facility Name
Michael Washburn Center for Ophthalmic Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
Vance Thompson Vision, MN Site
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Ophthalmology Consultants, Ltd
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Vance Thompson Vision, MT Site
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Vance Thompson Vision NE Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Facility Name
Center For Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Eye Associates & SurgiCenter
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08361
Country
United States
Facility Name
Vance Thompson Vision ND Site
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Associates in Ophthalmology Ltd
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Vance Thompson Vision. SD Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States
Facility Name
Parkhurst Nuvision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Eye Institute of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Safety and Effectiveness of a Trifocal IOL

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