Clinical trial NCT04176965: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eye Diseases
Postcataract Aphakia
Cataract
Lens Opacities
Keywords: Intraocular Lens
Multifocal
Hydrophobic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 539
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes
timeFrame: 150-180 days after surgery on the first eyes
measure: Mean Photopic Monocular logMAR Distance Corrected Near Visual Acuity (DCNVA) for the First Operative Eyes.
timeFrame: 150-180 days after surgery on the first eyes
measure: Percentage of 1st Operative Eyes With Secondary Surgical Interventions (SSIs) Related to Optical Properties of IOL for up to Month 12 (Visit 5)
timeFrame: Up to Month 12 (Day 360-420), post first eye implantation
measure: Mean Monocular Distance Log Contrast Sensitivity Photopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
timeFrame: Month 12 (Day 360-420), post-first eye implantation
measure: Mean Monocular Distance Log Contrast Sensitivity Photopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
timeFrame: Month 12 (Day 360-420), post-first eye implantation
measure: Mean Monocular Distance Log Contrast Sensitivity Mesopic Without Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
timeFrame: Month 12 (Day 360-420), post-first eye implantation
measure: Mean Monocular Distance Log Contrast Sensitivity Mesopic With Glare at 2.5 m in 1st Operative Eyes at Month 12 (Visit 5).
timeFrame: Month 12 (Day 360-420), post-first eye implantation
Secondary outcomes:
measure: Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
timeFrame: 150-180 days after surgery on the first eye
measure: Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7
timeFrame: Month 12 (Day 360-420), post-first eye implantation
measure: Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)
timeFrame: Month 12 (Day 360-420), post-first eye implantation
Other outcomes:
Locations:
city: Northridge
country: United States
facility: Mitchell C Shultz MD/Shultz Chang Vision
state: California
city: Orange
country: United States
facility: Coastal Vision Medical Group
state: California
city: Orland Park
country: United States
facility: Arbor Centers for Eye Care
state: Illinois
city: Indianapolis
country: United States
facility: Michael Washburn Center for Ophthalmic Research
state: Indiana
city: Alexandria
country: United States
facility: Vance Thompson Vision, MN Site
state: Minnesota
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd
state: Missouri
city: Bozeman
country: United States
facility: Vance Thompson Vision, MT Site
state: Montana
city: Omaha
country: United States
facility: Vance Thompson Vision NE Site
state: Nebraska
city: Las Vegas
country: United States
facility: Center For Sight
state: Nevada
city: Vineland
country: United States
facility: Eye Associates & SurgiCenter
state: New Jersey
city: W. Fargo
country: United States
facility: Vance Thompson Vision ND Site
state: North Dakota
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: West Mifflin
country: United States
facility: Associates in Ophthalmology Ltd
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Vance Thompson Vision. SD Site
state: South Dakota
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
city: San Antonio
country: United States
facility: Parkhurst Nuvision
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
Study officials:
References: