h25 H26
Conditions
Interventions
Group 1: Subjects meeting the criteria in either one or both eyes will be implanted with the TECNIS 1-piece intraocular lens Model ZCB00 using the New Cartridge Delivery System.
Sponsors
Johnson and Johnson Surgical Vision, Inc.
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: • Minimum 22 years of age • Unilateral or bilateral cataracts for which IOL implantation are planned • Planned small-incision cataract surgery with implantation of a TECNIS® 1-piece IOL, Model ZCB00 in the diopter range of +16.00 to +28.00 • Clear intraocular media, other than cataract • Availability, willingness and sufficient cognitive awareness to comply with examination procedures • Ability to understand, read, and write English. • Signed informed consent and documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Exclusion criteria
Exclusion criteria: • Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D • Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils) • Recent ocular trauma or ocular surgery that is not resolved/stable or may increase risk to the subject • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects • Prior, current, or anticipated use during the course of the study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery) • Poorly-controlled diabetes • Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes is acceptable. • Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RATE OF ACCEPTABLE OVERALL CLINICAL PERFORMANCE - The overall clinical performance of the New Cartridge Delivery System will be considered acceptable if the combined percentage of investigator/surgeon per-eye ratings of 3 or higher for acceptable overall clinical performance is at least 95%, based on the responses of the Investigator Per-Eye Day of Surgery Questionnaire. The Investigator Per-Eye Day of Surgery Questionnaire will be completed following each surgical case by the surgeon. | — |
Countries
Australia, New Zealand
Contacts
Public ContactCheryl Harper
Johnson and Johnson Surgical Vision, Inc.
Outcome results
None listed