H25.8
Conditions
Interventions
Group 1: 1 eye is operated on using the Centurion phacoemulsification system and the Active Sentry handpiece set to low pressure
Group 2: The other eye is operated on using the Stellaris Elite’s conve
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - male and female adults with bilateral age related uncomplicated cataract - Enrolled subjects with an inter-eye difference of =2 Opacity Grades as measured by iTrace - ECC >800 - central corneal thickness: CCT>400µm, CCT<650µm - Clear ocular media other than cataract, especially clear corneal layers - Availibility, willingness, ability and sufficient cognitive awareness to comply with examination procedures and clinical investigation visits - Ability to consent to the participation in clinical investigation - Signed informed consent
Exclusion criteria
Exclusion criteria: - Requires a legal representative or cannot read or understand the ICF - Intraocular inflammation or recurrent ocular inflammatory condition - Previous ocular surgery including corneal refractive surgery - corneal pathology, such as cornea guttata, fuchs endothelial dystrophy or keratoconus, that could increase the risk to develop corneal decompensation or ectasia postoperatively - significantly reduced endothelial cell count: ECC650µm - instability of biometry measurements - continuous contact lens wearing within 6 months of the preoperative examination for PMMA contact lenses, within 1 month of the preoperative for gas permeable lenses, or within 3 weeks of the preoperative examination for extended-wear and daily wear of soft contact lenses - serious dry eyes that could distort endothelial and pachymetry measurement or affect vision - increased risk of glaucomatous attack - conditions associated with increased risk of zonula rupture, including capsular or zonula abnormalities that may lead IOL decentration, including pseudoexfoliation, trauma or posterior capsule defects - conditions (e.g. pregnancy, plan to become pregnant, lactating, ect.) associated with fluctuation of hormones that could lead to significant refractive or biometric changes - participation in any other clinical trial during the last 30 days - inability to focus, fixate or do vision test - physical or mental limitations that make follow-up examinations impossible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| monocular change in central corneal thickness (CCT) from pre to 1 day post operative (C.S.O. Sirius) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Monocular change from pre to central corneal thickness (CCT) at 1 week and 12 weeks postoperative (C.S.O. Sirius) - Monocular change in endothelial cell count (ECC) from pre to 1 and 12 weeks post operative time point as measured (CEM530) - best corrected distance visual acuity (BCDVA) 1st day, 1 week and 12 weeks postoperative - anterior chamber stability questionnaire (1-4 grading) to be filled in by surgeon post-operatively - number of instable anterior chamber events as determined by video grader, including : - number of iris movement defined as number of times iris is seen to bow or move forward (i.e. fluctuate) - number of pupillary size changes defines as number of iris constriction or dilations - Subgroup analysis of central corneal thickness changes from preoperative to 1 day via opacity grade measurement (iTrace) - Total time that phaco tip is in the eye (seconds) as measured by video grader | — |
Countries
Germany
Contacts
Public ContactEckart Bertelmann
Charité - Universitätsmedizin Berlin
Outcome results
None listed