An interventional study of Stellaris Elite in Cataract, sponsored by Prim. Prof. Dr. Oliver Findl, MBA. Status unknown at 1 site in Austria. Open to participants aged 21 Years to 105 Years. Per ClinicalTrials.gov, last updated 2018-11-23.
Sponsored by Prim. Prof. Dr. Oliver Findl, MBA · Not applicable, Interventional, and Other
Clinical performance of phacoemulsification platform Stellaris Elite with standard irrigation fluid bottles in myopic eyes. Anterior chamber depth and patients comfort will be compared between the two groups.
Today phacoemulsification is the most important and safest procedure to perform cataract surgery. However, there are factors that can increase the risk of complications, one of them is an intraoperative increase of intraocular pressure (IOP) which may cause choroidal haemorrhage, capsular block syndrome, or posterior capsular rupture .
Also, more regularly, alterations of IOP provoke sudden changes of the anterior chamber depth, especially in myopic eyes due to intra-operative inverse irido-capsular block, which may result in pain or discomfort for the patient. The deepening of the chamber also makes the surgical maneuvers more challenging in such eyes.
As prevention of such adverse events, it is important to maintain a more or less constant IOP intraoperatively. To ensure this, the pressure of the irrigation fluid must be adjusted to the outflow of aqueous humor, usually by adapting the height of the irrigation fluid bottle (passive fluidics system). As a variable vacuum is produced at the phaco tip to enable the suction of lens fragments, there often are fluctuations of IOP, therefore the surgeon is required to constantly adjust the height of the irrigation fluid bottle.
A novel method to relieve the surgeon of this often-distracting task is to use all-in-one phacoemulsification systems that are able to monitor vacuum flow rates and then adjust the pressure of the irrigation fluid intraoperatively, also resulting in less fluctuations of IOP (active fluidics system). This should also result in reduced deepening of the anterior chamber and less risk of the adverse events as explained above.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 35 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Prim. Prof. Dr. Oliver Findl, MBA is the lead sponsor of 38 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
In myopic patients with axial length over 25.0 mm during surgery of the first eye the Stellaris platform will be used and during surgery of the second eye the Stellaris Elite platform will be used
Device: Stellaris Elite
The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length \> 25.0 mm) during cataract surgery
Anterior chamber depth
Anterior chamber depth will be measured using the IOL Master 700. Fluctuations in anterior chamber depth will be compared between the eyes where Stellaris and the contralateral eyes in which the Stellaris Elite platform was used
Time frame: 12 months
Patients discomfort
Patients will be asked concerning their discomfort during both cataract surgeries and results will be recorded using an visual analogue scale. In the visual analogue scale 10 means highest discomfort and 1 stands for lowest discomfort.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
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Prim. Prof. Dr. Oliver Findl, MBA