NCT03751254

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

November 21, 2018

Last Update Submit

November 21, 2018

Conditions

Cataract

Keywords

CataractCataract surgeryPhacoemulsification platform

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • Patients discomfort

    12 months

Study Arms (1)

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

Device: Stellaris Elite

Interventions

Stellaris EliteDEVICE

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

Myopic patients

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Kristina Stjepanek, MD

CONTACT

01 91021-57564office@viros.at

Julius Hienert, MD

CONTACT

01 91021-57564office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 23, 2018

Study Start

October 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 23, 2018

Record last verified: 2018-11

Locations

AU(1)