Investigation of the Safety and Effectiveness of a Trifocal IOL

Cataract Clinical Trial

Official title:

Clinical Investigation of the Safety and Effectiveness of FINEVISION HP Trifocal IOL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04176965
• Other study ID #: PHY1903
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: November 9, 2023

Study information

• Verified date: September 2023
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 501
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Aphakia
• Aphakia, Postcataract
• Cataract
• Eye Diseases
• Lens Opacities

Intervention

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

Locations

Country	Name	City	State
United States	Vance Thompson Vision, MN Site	Alexandria	Minnesota
United States	Chu Vision Institute	Bloomington	Minnesota
United States	Vance Thompson Vision, MT Site	Bozeman	Montana
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Michael Washburn Center for Ophthalmic Research	Indianapolis	Indiana
United States	Center For Sight	Las Vegas	Nevada
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	Mitchell C Shultz MD/Shultz Chang Vision	Northridge	California
United States	Vance Thompson Vision NE Site	Omaha	Nebraska
United States	Coastal Vision Medical Group	Orange	California
United States	Arbor Centers for Eye Care	Orland Park	Illinois
United States	Ophthalmology Consultants, Ltd	Saint Louis	Missouri
United States	The Eye Institute of Utah	Salt Lake City	Utah
United States	Parkhurst Nuvision	San Antonio	Texas
United States	Vance Thompson Vision. SD Site	Sioux Falls	South Dakota
United States	Eye Associates & SurgiCenter	Vineland	New Jersey
United States	Vance Thompson Vision ND Site	W. Fargo	North Dakota
United States	Associates in Ophthalmology Ltd	West Mifflin	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	150-180 days after surgery on the first eye
Primary	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)	150-180 days after surgery on the first eye
Secondary	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	150-180 days after surgery on the first eye