h25 H26
Conditions
Interventions
Group 1: Investigational bacterially-derived Healon PRO OVD (ophthalmic viscosurgical device) for standard, small incision cataract surgery
Group 2: Control animal-derived Healon OVD (ophthalmic visco
Sponsors
Johnson and Johnson Vision
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • Rate of IOP spikes 30 mmHg or greater at 1- day postoperative • Mean IOP at 1-day postoperative • Mean change of IOP from baseline (postoperative IOP minus baseline IOP) • Investigator Questionnaire at the operative visit • Serious or Device-Related Adverse Events | — |
Countries
Germany, Spain
Contacts
Public ContactRosangela Nolasco, DMD, MPH
Johnson and Johnson Vision
Outcome results
None listed