Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens

Cataract Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Active-Controlled Clinical Study to Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens in Subjects Undergoing Cataract Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03603600
• Other study ID #: 945
• Status: Completed
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: May 4, 2023

Study information

• Verified date: December 2023
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

Description:

Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: May 4, 2023
• Est. primary completion date: May 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.

2. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.

3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.

4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.

5. Subjects must have clear intraocular media other than the cataract in both eyes.

Exclusion Criteria:

1. Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.

2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye.

3. Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.

4. Subjects who have uncontrolled glaucoma in either eye.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• enVista MX60E
enVista MX60E monofocal IOL
• enVista MX60EF
enVista MX60EF (trifocal) multifocal IOL (MIOL)

Locations

Country	Name	City	State
United States	Bausch Site 119	Birmingham	Mississippi
United States	Bausch Site 101	Bloomington	Minnesota
United States	Bausch Site 106	Brecksville	Ohio
United States	Bausch Site 104	Cedar Park	Texas
United States	Bausch Site 109	Columbus	Ohio
United States	Bausch Site 105	Dallas	Texas
United States	Bausch Site 108	Fayetteville	Arkansas
United States	Bausch Site 113	Garden Grove	California
United States	Bausch Site 111	Houston	Texas
United States	Bausch Site 117	Lake Villa	Illinois
United States	Bausch Site 118	Las Vegas	Nevada
United States	Bausch Site 112	Memphis	Tennessee
United States	Bausch Site 107	Mount Dora	Florida
United States	Bausch Site 110	Nashville	Tennessee
United States	Bausch Site 120	Northridge	California
United States	Bausch Site 124	Omaha	Nebraska
United States	Bausch Site 116	Pittsburgh	Pennsylvania
United States	Bausch Site 115	Redding	California
United States	Bausch Site 102	Saint Louis	Missouri
United States	Bausch Site 122	San Antonio	Texas
United States	Bausch Site 123	San Antonio	Texas
United States	Bausch Site 121	Sioux Falls	South Dakota
United States	Bausch Site 103	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photopic monocular best-corrected distance visual acuity (BCDVA)	Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)	Day 120 to Day 180 after second eye implantation
Primary	Photopic monocular distance-corrected near visual acuity (DCNVA)	Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)	Day 120 to Day 180 after second eye implantation
Primary	Photopic monocular distance-corrected intermediate visual acuity (DCIVA)	Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation	Day 120 to Day 180 after second eye implantation