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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataract

Treatments: Device: Tecnis Eyhance; Device: Tecnis 1 piece IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05025345

EMON-101-EHCE

Details and patient eligibility

About

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.

Enrollment: 228 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 2 patient groups

Study Lens

Experimental group

Description:

Tecnis Eyhance

Treatment:

Device: Tecnis Eyhance

Control Lens

Active Comparator group

Description:

Tecnis 1 piece IOL (Intraocular lens)

Treatment:

Device: Tecnis 1 piece IOL