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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
Completed
CT.gov ID
NCT05025345
Collaborator
(none)
228
Enrollment
15
Locations
2
Arms
9.5
Actual Duration (Months)
15.2
Patients Per Site
1.6
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 Disease Intervention/Treatment Phase
  • Device: Tecnis Eyhance
  • Device: Tecnis 1 piece IOL
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
228 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
Actual Primary Completion Date :
Jan 21, 2022
Actual Study Completion Date :
Jun 17, 2022

Arms and Interventions

Arm Intervention/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

Site City State Country Postal Code
1 Empire Eye & Laser Center Bakersfield California United States 93309
2 Southern California Eye Physicians and Associates Long Beach California United States 90805
3 Center For Sight Sarasota Florida United States 34239
4 Jones Eye Clinic Sioux City Iowa United States 51104
5 Chesapeake Eye Care & Laser Center Annapolis Maryland United States 21401
6 Tekwani Vision Center Saint Louis Missouri United States 63128
7 Scott & Christie and Associates, PC Cranberry Township Pennsylvania United States 16606
8 Eye Care Specialists Kingston Pennsylvania United States 18704
9 Key-Whitman Eye Center Dallas Texas United States 75243
10 Berkeley Eye Institute, P.A. Houston Texas United States 77027
11 Whitsett Vision Group Houston Texas United States 77055
12 Texas Eye and Laser Center Hurst Texas United States 76054
13 Focal Point Vision San Antonio Texas United States 78209
14 Parkhurst NuVision San Antonio Texas United States 78229
15 R & R Eye Research, LLC San Antonio Texas United States 78229

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:
Jul 13, 2022
Last Verified:
Jul 1, 2022
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:
Cataract

Study Results

No Results Posted as of Jul 13, 2022