Clinical Handleability and Acceptability Assessment of the New Modular Cartridge Delivery System
- Conditions
- h25H26Senile cataractOther cataract
- Registration Number
- DRKS00014757
- Lead Sponsor
- Johnson and Johnson Surgical Vision, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 84
• 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
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method RATE OF ACCEPTABLE OVERALL CLINICAL PERFORMANCE - <br>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. <br><br>The Investigator Per-Eye Day of Surgery Questionnaire will be completed following each surgical case by the surgeon.
- Secondary Outcome Measures
Name Time Method