N/A
Completed N=101
Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)
Cataract · Astigmatism
Source: ClinicalTrials.gov NCT02649842 ↗
Enrolled (actual)
101
Serious AEs
18.8%
Results posted
Dec 2019
Primary outcomePrimary: Rate of Severe Visual Distortions — 3 Participants
Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Severe Visual Distortions |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.
- 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 or 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
- 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 or is lactating
Data sourced from ClinicalTrials.gov (NCT02649842). 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.