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Completed

NCT Number: NCT05090813

A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens

This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.

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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

Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6

Qionghai, Hainan, 571434, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients at least 22 years of age
  • Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
  • Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
  • Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion criteria

  • Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
  • Planned monovision correction (one eye designated for near correction).
  • Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Treatment and study plan

Model ICB00

Device

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

Primary outcomes

  1. mean monocular postoperative DCIVA

    Time frame: 6 months

  2. percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2021
Registry last updated
May 23, 2025

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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