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OpenTrials
Completed

NCT Number: NCT06377514

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

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

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Empire Eye & Laser Center, Bakersfield, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Test IOL Model DEN00V

Device

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

Device

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

Primary outcomes

  1. Monocular (First Eyes) Photopic DCIVA at 66 cm

    Time frame: 6 months

    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) in logMAR at 66 cm for first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

  2. Monocular (First Eyes) Depth of Focus

    Time frame: 6 months

    Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero diopter) for first eyes. The data values reported represent the diopter of defocus at which the mean visual acuity for all participants crosses the 0.20 logMAR threshold. Therefore, the values reported are represented as a single value for each arm. This analysis was prespecified for the first operative eye.

  3. Monocular (First Eyes) Photopic BCDVA at 4m

    Time frame: 6 months

    Monocular photopic best-corrected distance visual acuity (BCDVA) in logMAR at 4 meters for the first eyes. Note that a lower logMAR value denotes better visual acuity. The difference in mean visual acuity is calculated as control group minus test group. This analysis was prespecified for the first operative eye.

  4. Monocular (First Eyes) Photopic DCVA at 100 cm

    Time frame: 6 months

    Monocular photopic Distance Corrected Visual Acuity (DCVA) in logMAR at 100 cm for first eyes. This analysis was prespecified for the first operative eye.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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