Comparison of Stellaris Standard Infusion With Stellaris Elite

NCT ID: NCT03751254

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-12-01

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Myopic patients

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

Group Type: EXPERIMENTAL

Stellaris Elite

Intervention Type: DEVICE

The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length \> 25.0 mm) during cataract surgery

Interventions

Stellaris Elite

The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length \> 25.0 mm) during cataract surgery

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Kristina Stjepanek, MD

Role: CONTACT

office@viros.at

01 91021-57564

Julius Hienert, MD

Role: CONTACT

office@viros.at

01 91021-57564

Facility Contacts

Kristina Stjepanek, MD

Role: primary

office@viros.at

01 910 21-57564

Julius Hienert, MD

Role: backup

office@viros.at

01 91021-57564

Other Identifiers

Stellaris

Identifier Type: -

Identifier Source: org_study_id