Clinical trial NCT03791619: Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Official title: Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-02
Enrollment: 475
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of Bothersome Visual Symptoms
timeFrame: 6-month
measure: Rate of Difficulty With an Activity Due to the Visual Symptoms
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Long Beach
country: United States
facility: Southern California Eye Physicians & Associates
state: California
city: Santa Monica
country: United States
facility: Santa Monica Eye Medical Group
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Bradenton
country: United States
facility: The Eye Associates of Manatee
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Jacksonville
country: United States
facility: North Florida Eye Surgeons, LLC dba Florida Eye Specialist
state: Florida
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: Rock Island
country: United States
facility: Virdi Eye Clinic & Laser Vision Care
state: Illinois
city: Annapolis
country: United States
facility: Chesapeake Eye Care & Laser
state: Maryland
city: Birmingham
country: United States
facility: Oakland Ophthalmic Surgery
state: Michigan
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute PA
state: New Jersey
city: Chambersburg
country: United States
facility: Ludwick Eye Center
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Memphis
country: United States
facility: Memphis Eye & Cataract Associates, PLLC
state: Tennessee
city: Dallas
country: United States
facility: Cornea Associates of Texas
state: Texas
city: Hurst
country: United States
facility: Texas Eye & Laser Center
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Lacey
country: United States
facility: Clarus Eye Centre
state: Washington
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: