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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-24

Study Completion Date

2024-04-22

Brief Summary

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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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Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TECNIS Eyhance IOL

Model ICB00

Group Type EXPERIMENTAL

Model ICB00

Intervention Type DEVICE

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

Interventions

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Model ICB00

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients at least 22 years of age
2. 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
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Planned monovision correction (one eye designated for near correction).
3. 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.).

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No