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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: Study Lens|
Device: Tecnis Eyhance
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
|Active Comparator: Control Lens|
Tecnis 1 piece IOL (Intraocular lens)
Device: Tecnis 1 piece IOL
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Primary Outcome Measures
- Distance-corrected Intermediate Visual Acuity at 66 cm (DCVA66) [6 months postoperative]
Secondary Outcome Measures
- Best-corrected Distance Visual Acuity (BCDVA) [6 months postoperative]
- Distance-corrected Intermediate Visual Acuity at 50 cm (DCVA50) [6 months postoperative]
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
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
Contacts and Locations
|1||Empire Eye & Laser Center||Bakersfield||California||United States||93309|
|2||Southern California Eye Physicians and Associates||Long Beach||California||United States||90805|
|3||Center For Sight||Sarasota||Florida||United States||34239|
|4||Jones Eye Clinic||Sioux City||Iowa||United States||51104|
|5||Chesapeake Eye Care & Laser Center||Annapolis||Maryland||United States||21401|
|6||Tekwani Vision Center||Saint Louis||Missouri||United States||63128|
|7||Scott & Christie and Associates, PC||Cranberry Township||Pennsylvania||United States||16606|
|8||Eye Care Specialists||Kingston||Pennsylvania||United States||18704|
|9||Key-Whitman Eye Center||Dallas||Texas||United States||75243|
|10||Berkeley Eye Institute, P.A.||Houston||Texas||United States||77027|
|11||Whitsett Vision Group||Houston||Texas||United States||77055|
|12||Focal Point Vision||San Antonio||Texas||United States||78209|
|13||Parkhurst NuVision||San Antonio||Texas||United States||78229|
|14||R & R Eye Research, LLC||San Antonio||Texas||United States||78229|
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision
Study Documents (Full-Text)None provided.