Post-Approval Study of the TECNIS SYMFONY® Toric Lenses

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.

Completed

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Key information

Conditions

Cataract Astigmatism Corneal Astigmatism Eye Diseases Lens Diseases Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Empire Eye & Laser Center, Bakersfield, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Cylinder Toric IOL

Device

Symfony Toric models ZXT300 and ZXT375 IOL

Lower Cylinder Toric IOL

Device

Symfony Toric model ZXT150 IOL

Primary outcomes

Rate of Bothersome Visual Symptoms

Time frame: 6-month

The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Rate of Difficulty With an Activity Due to the Visual Symptoms

Time frame: 6-month

The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Acronym: ANCORA

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jan 2, 2019
Registry last updated: Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed