- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825264
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Liège, Belgium, 4000
- Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.
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Lyon, France, 69317
- Hospital de la Croix-Rousse
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Paris, France, 75571
- CHNO des Quinze-Vingts
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Dortmund, Germany, 44137
- St. Johannes Hospital Dortmund
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Heidelberg, Germany, 69120
- Universitäts-Augenklinik Heidelberg
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München, Germany, 81377
- Klinikum der Universität München
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Rostock, Germany, 18057
- Augenklinik Universitätsmedizin Rostock
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Sopron, Hungary, 9400
- Elisabeth Academic Hospital
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Madrid, Spain
- Hospital Ramon y Cajal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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STARflo
Patients who have been implanted with STARflo implant
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All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of intraocular pressure (IOP)
Time Frame: at 12 Months
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IOP reduction compared after 12 months compared to baseline IOP
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at 12 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of Ocular Adverse Events
Time Frame: up to 60 Months after surgery
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to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery
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up to 60 Months after surgery
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Reduction of intraocular pressure (IOP) over time
Time Frame: at 6, 24, 36, 48 and 60 Months
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IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP
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at 6, 24, 36, 48 and 60 Months
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Reduction of IOP lowering medication
Time Frame: at 6, 12, 24, 36, 48 and 60 Months
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Reduction of IOP lowering medication intake compare to baseline
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at 6, 12, 24, 36, 48 and 60 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Zubair Hussain, PhD, Sponsor Representative
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISM03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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