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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

Tracking Information
First Submitted Date June 20, 2016
First Posted Date July 7, 2016
Last Update Posted Date November 29, 2018
Actual Study Start Date July 2016
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2017)
Reduction of intraocular pressure (IOP) [ Time Frame: at 12 Months ]
IOP reduction compared after 12 months compared to baseline IOP
Original Primary Outcome Measures
 (submitted: July 6, 2016)
Intra-ocular pression (IOP) [ Time Frame: at 24 Months ]
IOP reduction compared to baseline
Change History Complete list of historical versions of study NCT02825264 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 16, 2017)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: July 6, 2016)
  • Occurence of Ocular Adverse Events [ Time Frame: During surgery and over the study period, up to 60 Months after surgery ]
    to record and document all surgery related complications and ocular Adverse Events/Adverse Device Effects occurred during and after surgery
  • Intra-ocular pression (IOP) over time [ Time Frame: at 6, 12, 36, 48 and 60 Months ]
    IOP reduction compare to baseline
  • IOP medication intake over time [ Time Frame: at 6, 12, 24, 36, 48 and 60 Months ]
    IOP lowering medication intake compare to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program
Official Title STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Open Angle Glaucoma
Intervention Device: STARflo Implant
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection
Study Groups/Cohorts STARflo
Patients who have been implanted with STARflo implant
Intervention: Device: STARflo Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 6, 2016)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anne Kroker, PhD +49 1608548809 annek@istarmed.com
Listed Location Countries Belgium,   France,   Germany,   Hungary,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02825264
Other Study ID Numbers ISM03
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party iSTAR Medical
Study Sponsor iSTAR Medical
Collaborators Not Provided
Investigators
Study Chair: Zubair Hussain, PhD Sponsor Representative
PRS Account iSTAR Medical
Verification Date November 2018