Clinical trial NCT05025345: Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses
Official title: Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 228
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)
timeFrame: 6 months
Secondary outcomes:
measure: MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Long Beach
country: United States
facility: Southern California Eye Physicians and Associates
state: California
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Annapolis
country: United States
facility: Chesapeake Eye Care & Laser Center
state: Maryland
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Institute, P.A.
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Hurst
country: United States
facility: Texas Eye and Laser Center
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: San Antonio
country: United States
facility: R & R Eye Research, LLC
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: