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

NCT05396599 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-06-04

Study results available
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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

Interventions

DEVICE

Model DIU

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.

DEVICE

Model DFW

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.

DEVICE

Model ZCT

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.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-04-07
Completion
2023-04-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05396599 on ClinicalTrials.gov