Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Johnson & Johnson (J&J)

Status: Enrolling

Conditions: Cataracts

Treatments: Device: Test IOL Model DEN00V; Device: Control IOL Model DCB00

Study type: Interventional

Funder types: Industry

Identifiers

NCT06377514

PCOL109PHNG

Details and patient eligibility

About

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Enrollment: 250 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

To be considered for enrollment in this study, patient must:

• 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
• be available for study follow-up visits EXCLUSION CRITERIA

Patient will not be eligible to take part in the study if:

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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250 participants in 2 patient groups

Test IOL

Experimental group

Description:

DEN00V

Treatment:

Device: Test IOL Model DEN00V

Control IOL

Active Comparator group

Description:

DCB00

Treatment:

Device: Control IOL Model DCB00