Comparison of Stellaris Standard Infusion With Stellaris Elite

Prim. Prof. Dr. Oliver Findl, MBA

Status: Unknown

Conditions: Cataract

Treatments: Device: Stellaris Elite

Study type: Interventional

Funder types: Other

Identifiers

NCT03751254

Stellaris

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 21 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Myopic patients

Experimental group

Description:

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

Treatment:

Device: Stellaris Elite