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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05025345
Collaborator
(none)
220
Enrollment
14
Locations
2
Arms
13.9
Anticipated Duration (Months)
15.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Tecnis Eyhance
  • Device: Tecnis 1 piece IOL
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses
Actual Study Start Date :
Sep 2, 2021
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Study Lens

Tecnis Eyhance

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.

Outcome Measures

Primary Outcome Measures

  1. Distance-corrected Intermediate Visual Acuity at 66 cm (DCVA66) [6 months postoperative]

Secondary Outcome Measures

  1. Best-corrected Distance Visual Acuity (BCDVA) [6 months postoperative]

  2. Distance-corrected Intermediate Visual Acuity at 50 cm (DCVA50) [6 months postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye & Laser CenterBakersfieldCaliforniaUnited States93309
2Southern California Eye Physicians and AssociatesLong BeachCaliforniaUnited States90805
3Center For SightSarasotaFloridaUnited States34239
4Jones Eye ClinicSioux CityIowaUnited States51104
5Chesapeake Eye Care & Laser CenterAnnapolisMarylandUnited States21401
6Tekwani Vision CenterSaint LouisMissouriUnited States63128
7Scott & Christie and Associates, PCCranberry TownshipPennsylvaniaUnited States16606
8Eye Care SpecialistsKingstonPennsylvaniaUnited States18704
9Key-Whitman Eye CenterDallasTexasUnited States75243
10Berkeley Eye Institute, P.A.HoustonTexasUnited States77027
11Whitsett Vision GroupHoustonTexasUnited States77055
12Focal Point VisionSan AntonioTexasUnited States78209
13Parkhurst NuVisionSan AntonioTexasUnited States78229
14R & R Eye Research, LLCSan AntonioTexasUnited States78229

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT05025345
Other Study ID Numbers:
  • EMON-101-EHCE
First Posted:
Aug 27, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021