Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

NCT05025345 | Completed Results FDA Device

• 1 other identifier: EMON-101-EHCE
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 15

Brief Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL. The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)

  the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups

  6 months

Secondary Outcomes (1)

• MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)

  6 months

Study Arms (2)

Study Lens

EXPERIMENTAL

Tecnis Eyhance

Device: Tecnis Eyhance

Control Lens

ACTIVE COMPARATOR

Tecnis 1 piece IOL (Intraocular lens)

Device: Tecnis 1 piece IOL

Interventions

Tecnis Eyhance DEVICE

Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Study Lens

Tecnis 1 piece IOL DEVICE

Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Control Lens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
• Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
• Corneal astigmatism parameters:
• Normal corneal topography and no irregular corneal astigmatism
• Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
• Clear intraocular media other than cataract in each eye
• Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

You may not qualify if:

• Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (15)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Southern California Eye Physicians and Associates

Long Beach, California, 90805, United States

Location

Center For Sight

Sarasota, Florida, 34239, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

Chesapeake Eye Care & Laser Center

Annapolis, Maryland, 21401, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16606, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Berkeley Eye Institute, P.A.

Houston, Texas, 77027, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

Focal Point Vision

San Antonio, Texas, 78209, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

R & R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Luis Vargas, MD
• Organization: Johnson & Johnson Surgical Vision

LVarga17@ITS.JNJ.com

714-247-8200

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 27, 2021
• Study Start: September 2, 2021
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (15)