Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Control Lens	Tecnis 1 piece IOL	Tecnis 1 piece IOL (Intraocular lens)
Study Lens	Tecnis Eyhance	Tecnis Eyhance

Primary Outcome Measures

Name	Time	Method
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)	6 months	the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups

Secondary Outcome Measures

Name	Time	Method
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)	6 months	the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups

Locations (15): Berkeley Eye Institute, P.A.
🇺🇸
Houston, Texas, United States
Key-Whitman Eye Center
🇺🇸
Dallas, Texas, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, United States
Jones Eye Clinic
🇺🇸
Sioux City, Iowa, United States
Eye Care Specialists
🇺🇸
Kingston, Pennsylvania, United States
Whitsett Vision Group
🇺🇸
Houston, Texas, United States
Focal Point Vision
🇺🇸
San Antonio, Texas, United States
Parkhurst NuVision
🇺🇸
San Antonio, Texas, United States
Scott & Christie and Associates, PC
🇺🇸
Cranberry Township, Pennsylvania, United States
Center For Sight
🇺🇸
Sarasota, Florida, United States
Southern California Eye Physicians and Associates
🇺🇸
Long Beach, California, United States
Chesapeake Eye Care & Laser Center
🇺🇸
Annapolis, Maryland, United States
Tekwani Vision Center
🇺🇸
Saint Louis, Missouri, United States
Texas Eye and Laser Center
🇺🇸
Hurst, Texas, United States
R & R Eye Research, LLC
🇺🇸
San Antonio, Texas, United States