Post-Approval Study of the Tecnis® Toric IOL

Abbott

Status: Completed

Conditions: Cataract

Treatments: Device: toric intraocular lens; Device: non-toric intraocular lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02566083

TIOL-202-TPAS

Details and patient eligibility

About

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

Enrollment: 365 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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365 participants in 2 patient groups

non-toric intraocular lens

Active Comparator group

Description:

non-toric approved intraocular lens

Treatment:

Device: non-toric intraocular lens

toric intraocular lens

Active Comparator group

Description:

approved toric intraocular lens

Treatment:

Device: toric intraocular lens