h25 H26
Conditions
Interventions
Group 1: Subjects scheduled for cataract surgery will undergo preoperative testing with the Cassini Total Corneal Astigmatism instrument. The measurements will be imported into the CATALYS system and
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: • Minimum 22 years of age • Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned • Availability, willingness, sufficient cognitive awareness to comply with examination procedures • Clear intraocular media other than cataract • At least 0.5D of corneal cylinder (measured by Cassini or other keratometer or corneal topographer for which arcuate corneal incisions or use of toric IOL are planned • Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
Exclusion criteria
Exclusion criteria: • Any condition in the study eye which, in the Investigator's opinion, would confound the study results. • Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) • Concurrent participation or participation in any other interventional clinical trial during the duration of this clinical study including 30 days prior to study visit • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| “Overall clinical acceptability” will be calculated as the average score of the surgeon’s ratings for the following five questions on a five point rating scale* for each treated eye: o Satisfaction with import of preop diagnostic data o Satisfaction with automated input of arcuate incision parameter into treatment plan o Satisfaction with Iris registration o Satisfaction with steep meridian marking o Overall rating of satisfaction with workflow | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complications and adverse events | — |
Countries
Germany
Contacts
Public ContactSimone Beuter
Johnson & Johnson Vision
Outcome results
None listed