A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

NCT05396599 | Terminated Results FDA Device

• 1 other identifier: JJSV201EYST
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Rotational Stability of IOL

  The percentage of eyes with rotational stability of the IOL at postoperative 1 month.

  1 month

Study Arms (3)

Eyhance Toric II IOL

EXPERIMENTAL

Model DIU

Device: Model DIU

TECNIS Synergy Toric II

EXPERIMENTAL

Model DFW

Device: Model DFW

TECNIS Toric 1-Piece IOL

ACTIVE COMPARATOR

Model ZCT

Device: Model ZCT

Interventions

Model DIU DEVICE

Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

Eyhance Toric II IOL

Model DFW DEVICE

Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

TECNIS Synergy Toric II

Model ZCT DEVICE

Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

TECNIS Toric 1-Piece IOL

Eligibility Criteria

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

You may qualify if:

• Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
• Male or female at least 22 years of age
• Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens
• Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s)
• Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative 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.

You may not qualify if:

• Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
• Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR)
• Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR)
• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
• Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
• Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm)
• Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures)
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
• Poorly controlled diabetes
• Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
• Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
• Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
• Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (5)

Shultz Chang Vision

Los Angeles, California, 91325, United States

Location

Coastal Vision

Orange, California, 92868, United States

Location

Pacific Eye Associates, A Medical Corporation

San Francisco, California, 94115, United States

Location

Aloha Vision Consultants

Honolulu, Hawaii, 96817, United States

Location

Parkhurst NuVision

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, Inc. Clinical Trial

  Johnson & Johnson Surgical Vision, Inc.

  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: May 25, 2022
• First Posted: May 31, 2022
• Study Start: June 30, 2022
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (5)