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Completed

NCT Number: NCT03500198

Clinical Investigation of the Next Generation Intraocular Lens

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolstan & Goldberg Eye Associates, Torrance, California, United States

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About this study

The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum 22 years of age
  • Bilateral cataracts for which posterior chamber IOL implantation has been planned
  • Corneal astigmatism:
  • Normal corneal topography
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study 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
  • Ability to understand and respond to a questionnaire in English

Exclusion criteria

  • Irregular corneal astigmatism
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
  • Poorly-controlled diabetes
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
  • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

Treatment and study plan

Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Device

Intraocular lens replaces the natural lens removed during cataract surgery.

Control Monofocal Intraocular Lens: TECNIS Monofocal IOL

Device

Intraocular lens replaces the natural lens removed during cataract surgery.

Primary outcomes

  1. Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)

    Time frame: 6 months (postoperative)

    Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.

  2. Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve

    Time frame: 6 months (postoperative)

    Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.

Secondary outcomes

  1. Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm

    Time frame: 6 months (postoperative)

    Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.

  2. Overall Spectacle Wear

    Time frame: 6 months (postoperative)

    Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2018
Registry last updated
Jun 25, 2020

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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