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Clinical Trials/NCT03751254
NCT03751254UnknownNot Applicable

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

Prim. Prof. Dr. Oliver Findl, MBA1 site in 1 country35 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
35
Locations
1
Primary Endpoint
Anterior chamber depth

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
21 Years to 105 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Myopic patients

Experimental

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

Intervention: Stellaris Elite (Device)

Outcomes

Primary Outcomes

Anterior chamber depth

Time Frame: 12 months

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

Secondary Outcomes

  • Patients discomfort(12 months)

Investigators

Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

Study Sites (1)

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