Clinical Investigation of the Next Generation Intraocular Lens

Cataract Clinical Trial

Official title:

Clinical Investigation of the Safety and Effectiveness of the Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500198
• Other study ID #: SUR-IOL-652-2001
• Status: Completed
• Phase: N/A
• Start date: June 28, 2018
• Est. completion date: June 5, 2019

Study information

• Verified date: June 2020
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Description:

The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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

• Corneal astigmatism:

• Normal corneal topography

• Availability, willingness 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:

• Irregular corneal astigmatism

• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)

• Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs

• Poorly-controlled diabetes

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes

• 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:
• Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Intraocular lens replaces the natural lens removed during cataract surgery.
• Control Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intraocular lens replaces the natural lens removed during cataract surgery.

Locations

Country	Name	City	State
United States	The Eye Associates of Manatee, LLP	Bradenton	Florida
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Berkeley Eye Institute, P.A.	Houston	Texas
United States	Slade & Baker Vision	Houston	Texas
United States	Levenson Eye Associates, Inc.	Jacksonville	Florida
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Jones Eye Clinic	Sioux City	Iowa
United States	Vance Thompson Vision Clinic, Prof LLC	Sioux Falls	South Dakota
United States	Wolstan & Goldberg Eye Associates	Torrance	California

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, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)	Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.	6 months (postoperative)
Primary	Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve	Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only.	6 months (postoperative)
Secondary	Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only.	6 months (postoperative)
Secondary	Overall Spectacle Wear	Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time".	6 months (postoperative)