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STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

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ClinicalTrials.gov Identifier: NCT02825264
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

Brief Summary:
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

Condition or disease Intervention/treatment
Open Angle Glaucoma Device: STARflo Implant

Detailed Description:

This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.

This program is designed to be an international multicenter observational study.

Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.

The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
STARflo
Patients who have been implanted with STARflo implant
Device: STARflo Implant
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection




Primary Outcome Measures :
  1. Reduction of intraocular pressure (IOP) [ Time Frame: at 12 Months ]
    IOP reduction compared after 12 months compared to baseline IOP


Secondary Outcome Measures :
  1. Occurence of Ocular Adverse Events [ Time Frame: up to 60 Months after surgery ]
    to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery

  2. Reduction of intraocular pressure (IOP) over time [ Time Frame: at 6, 24, 36, 48 and 60 Months ]
    IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP

  3. Reduction of IOP lowering medication [ Time Frame: at 6, 12, 24, 36, 48 and 60 Months ]
    Reduction of IOP lowering medication intake compare to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.
Criteria

Inclusion criteria:

  • Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
  • Patients who have signed a Data Release form

Exclusion criteria:

  • Patients who did not sign a Data Release form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825264


Contacts
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Contact: Anne Kroker, PhD +49 1608548809 annek@istarmed.com

Locations
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Belgium
Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U. Active, not recruiting
Liège, Belgium, 4000
France
Hospital de la Croix-Rousse Active, not recruiting
Lyon, France, 69317
CHNO des Quinze-Vingts Active, not recruiting
Paris, France, 75571
CHNO des Quinze-Vingts Recruiting
Paris, France, 75571
Contact: Christophe Baudouin, Prof. Dr.         
Germany
St. Johannes Hospital Dortmund Recruiting
Dortmund, Germany, 44137
Contact: Markus Kohlhaas, Prof. Dr.         
Universitäts-Augenklinik Heidelberg Active, not recruiting
Heidelberg, Germany, 69120
Klinikum der Universität München Recruiting
München, Germany, 81377
Contact: Christoph Hirneiß, Prof. Dr.         
Augenklinik Universitätsmedizin Rostock Active, not recruiting
Rostock, Germany, 18057
Hungary
Elisabeth Academic Hospital Active, not recruiting
Sopron, Hungary, 9400
Spain
Hospital Ramon y Cajal Active, not recruiting
Madrid, Spain
Sponsors and Collaborators
iSTAR Medical
Investigators
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Study Chair: Zubair Hussain, PhD Sponsor Representative

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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT02825264     History of Changes
Other Study ID Numbers: ISM03
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by iSTAR Medical:
Glaucoma Drainage Device
STARflo

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases