Clinical trial NCT03751254: Comparison of Stellaris Standard Infusion With Stellaris Elite
Official title: Comparison of Phacoemulsification Platform Stellaris With Standard Infusion and Stellaris Elite With Pressurised Bottle in Myopic Eyes Concerning Deepening of Anterior Chamber as Measured by Intra-operative OCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Cataract
Cataract surgery
Phacoemulsification platform
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age-related cataract in both eyes
* Scheduled for bilateral cataract surgery
* Myopic patiens with axial eye length \>25.0mm
* Age 21 and older
* Written informed consent prior to recruitment

Exclusion Criteria:

* Pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
* Preceded ophthalmic surgery
* Any ophthalmic abnormality that could compromise the measurements
* Concurrent participation in another drug or device clinical investigation

Primary outcomes:
measure: Anterior chamber depth
timeFrame: 12 months
Secondary outcomes:
measure: Patients discomfort
timeFrame: 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS)
Study officials:
References: