Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens
NCT ID: NCT06377514
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
223 participants
INTERVENTIONAL
2024-06-03
2025-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Test IOL
DEN00V
Test IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive the Test IOL Model DEN00V in both eyes for the duration of the study
Control IOL
DCB00
Control IOL Model DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model DCB00 in both eyes for the duration of the study
Interventions
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Test IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive the Test IOL Model DEN00V in both eyes for the duration of the study
Control IOL Model DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model DCB00 in both eyes for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* be at least 22 years old
* have cataracts in both eyes
* sign the written informed consent
* be willing and able to comply with examination procedures
* understand, read and write English to complete informed consent and questionnaires
Exclusion Criteria
* currently participating in any other clinical study or have participated in a clinical study during the last 30 days
* have a certain disease/illness, such as poorly controlled diabetes
* have certain ocular conditions, such as uncontrolled pressure in the eye
* taking medication that may affect vision
* pregnant, plan to become pregnant during the study, or are breastfeeding
22 Years
ALL
Yes
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Surgical Vision, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Surgical Vision, Inc.
Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Jones Eye Center
Sioux City, Iowa, United States
OCLI Vision
Garden City, New York, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Berkeley Eye Center
Houston, Texas, United States
Whitsett Vision Group
Houston, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
Countries
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Other Identifiers
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PCOL109PHNG
Identifier Type: -
Identifier Source: org_study_id