Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Cataract Clinical Trial

— ANCORA  

Official title:

Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791619
• Other study ID #: TIOL-205-STPA
• Status: Completed
• Phase: N/A
• Start date: December 13, 2018
• Est. completion date: August 8, 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 prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• be at least 22 years old

• have cataracts in both eyes

• have a certain degree of astigmatism in at least one eye

• sign the written informed consent

• be willing and able to comply with examination procedures

• understand, read and write English to complete informed consent and questionnaires

• be available for study follow-up visits

Both eyes must qualify to be eligible to participate in the study

Exclusion Criteria:

• Currently participating in any other clinical study or have participated in a clinical study during the last 30 days

• Have a certain disease/illness such as poorly-controlled diabetes

• Have certain ocular conditions such as uncontrolled glaucoma

• Taking medication that may affect subject vision

• Have irregular corneal astigmatism

• Pregnant, plan to become pregnant during the study, or is breastfeeding

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

Device:
• Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
• Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL

Locations

Country	Name	City	State
United States	Chesapeake Eye Care & Laser	Annapolis	Maryland
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Oakland Ophthalmic Surgery	Birmingham	Michigan
United States	Florida Eye Microsurgical Institute, Inc.	Boynton Beach	Florida
United States	The Eye Associates of Manatee	Bradenton	Florida
United States	Ludwick Eye Center	Chambersburg	Pennsylvania
United States	Cornea Associates of Texas	Dallas	Texas
United States	Texas Eye & Laser Center	Hurst	Texas
United States	Levenson Eye Associates	Jacksonville	Florida
United States	North Florida Eye Surgeons, LLC dba Florida Eye Specialist	Jacksonville	Florida
United States	Clarus Eye Centre	Lacey	Washington
United States	Carolina Cataract & Laser Center	Ladson	South Carolina
United States	Southern California Eye Physicians & Associates	Long Beach	California
United States	Memphis Eye & Cataract Associates, PLLC	Memphis	Tennessee
United States	Virdi Eye Clinic & Laser Vision Care	Rock Island	Illinois
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	Santa Monica Eye Medical Group	Santa Monica	California
United States	Center For Sight	Sarasota	Florida
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Northern New Jersey Eye Institute PA	South Orange	New Jersey
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	Rate of Bothersome Visual Symptoms	The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.	6-month
Primary	Rate of Difficulty With an Activity Due to the Visual Symptoms	The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.	6-month