N/A
Completed N=365
Post-Approval Study of the Tecnis® Toric IOL
Source: ClinicalTrials.gov NCT02566083 ↗Enrolled (actual)
365
Serious AEs
13.2%
Results posted
Jan 2020
Primary outcomePrimary: Rate of Severe Visual Distortions — 189; 142; 0; 2 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Severe Visual Distortions |
189; 142; 0; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02566083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.