Post-Approval Study of the Tecnis® Toric IOL

This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Center South, Dothan, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Minimum 22 years of age
Bilateral cataracts
Preoperative keratometric cylinder in both eyes
Most appropriate toric IOL model choice (ZCT300 or ZCT400)
Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:

≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL

Clear intraocular media other than cataract in each eye
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
Signed informed consent and HIPAA authorization

Exclusion criteria

Irregular corneal astigmatism
Any corneal pathology/abnormality other than regular corneal astigmatism
Previous corneal surgery
Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
Any pupil abnormalities
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
Planned monovision correction
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

Treatment and study plan

non-toric intraocular lens

Device

TECNIS One-piece Monofocal Model ZCB00

Toric Intraocular lens

Device

TECNIS One-piece Toric Models ZCT300 or ZCT400

Primary outcomes

Rate of Severe Visual Distortions

Time frame: 6 months

The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2019
First posted: Oct 1, 2015
Registry last updated: Jan 18, 2020

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