Clinical Investigation of the Bacterially-Derived Healon Ophthalmic Viscosurgical Device (OVD)
- Conditions
- h25H26Senile cataractOther cataract
- Registration Number
- DRKS00016742
- Lead Sponsor
- Johnson and Johnson Vision
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 139
• Cataract for which extraction and posterior IOL implantation have been planned for one or both eyes
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent
• Pupil abnormalities
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Known steroid responder
• Ocular hypertension , medically-controlled ocular hypertension , or glaucomatous changes in the optic nerve
• 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
• Concurrent participation, or participation within 45 days prior to the preoperative visit, in any other clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of eyes with overall performance of the OVD being acceptable (defined as a score of 3, 4 or 5 for the overall clinical performance of OVD question) using an investigator questionnaire Rate the overall performance of the OVD on a 5-point scale
- Secondary Outcome Measures
Name Time Method • Rate of IOP spikes 30 mmHg or greater at 1- day postoperative<br>• Mean IOP at 1-day postoperative<br>• Mean change of IOP from baseline (postoperative IOP minus baseline IOP)<br>• Investigator Questionnaire at the operative visit<br>• Serious or Device-Related Adverse Events