Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
NCT ID: NCT05025345
Last Updated: 2023-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
228 participants
INTERVENTIONAL
2021-09-02
2022-06-17
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study Lens
Tecnis Eyhance
Tecnis Eyhance
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Control Lens
Tecnis 1 piece IOL (Intraocular lens)
Tecnis 1 piece IOL
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Interventions
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Tecnis Eyhance
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Tecnis 1 piece IOL
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Surgical Vision Clinical Trials
Role: STUDY_DIRECTOR
Johnson & Johnson Surgical Vision
Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Southern California Eye Physicians and Associates
Long Beach, California, United States
Center For Sight
Sarasota, Florida, United States
Jones Eye Clinic
Sioux City, Iowa, United States
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States
Tekwani Vision Center
St Louis, Missouri, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Berkeley Eye Institute, P.A.
Houston, Texas, United States
Whitsett Vision Group
Houston, Texas, United States
Texas Eye and Laser Center
Hurst, Texas, United States
Focal Point Vision
San Antonio, Texas, United States
Parkhurst NuVision
San Antonio, Texas, United States
R & R Eye Research, LLC
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EMON-101-EHCE
Identifier Type: -
Identifier Source: org_study_id
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