Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
Completed · Not applicable
Conditions studied: Cataract
In brief
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.
Key facts
- Study ID
- NCT05025345
- Run by
- Johnson & Johnson Surgical Vision, Inc.
- People needed
- 228
- Starts
- 2021-09-02
- Expected to finish
- 2022-06-17
- Last updated by the study team
- 2023-08-28
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.