Post-Approval Study of the TECNIS SYMFONY® Toric Lenses (ANCORA)

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataract; Corneal Astigmatism

Treatments: Device: Higher Cylinder Toric IOL; Device: Lower Cylinder Toric IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT03791619

TIOL-205-STPA

Details and patient eligibility

About

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.

Enrollment: 475 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

475 participants in 2 patient groups

Higher Cylinder Toric IOL

Active Comparator group

Description:

Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.

Treatment:

Device: Higher Cylinder Toric IOL

Lower Cylinder Toric IOL

Active Comparator group

Description:

Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group.

Treatment:

Device: Lower Cylinder Toric IOL