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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025345
• Other study ID #: EMON-101-EHCE
• Status: Completed
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: June 17, 2022

Study information

• Verified date: August 2023
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 17, 2022
• Est. primary completion date: June 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Tecnis Eyhance
Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
• Tecnis 1 piece IOL
Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)	the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups	6 months
Secondary	MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)	the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups	6 months