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Completed

NCT Number: NCT05025345

Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.

The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

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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

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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
  • Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
  • Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
  • Corneal astigmatism parameters:
  • Normal corneal topography and no irregular corneal astigmatism
  • Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
  • Clear intraocular media other than cataract in each eye
  • Availability, willingness, ability, 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

  • Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction

Treatment and study plan

Tecnis Eyhance

Device

Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Tecnis 1 piece IOL

Device

Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Primary outcomes

  1. MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)

    Time frame: 6 months

    the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups

Secondary outcomes

  1. MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)

    Time frame: 6 months

    the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 27, 2021
Registry last updated
Aug 28, 2023

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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