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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02825264
Other study ID # ISM03
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2016
Est. completion date December 2026

Study information

Verified date August 2022
Source iSTAR Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 70
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
STARflo Implant
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection

Locations

Country Name City State
Belgium Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U. Liège
France Hospital de la Croix-Rousse Lyon
France CHNO des Quinze-Vingts Paris
Germany St. Johannes Hospital Dortmund Dortmund
Germany Universitäts-Augenklinik Heidelberg Heidelberg
Germany Klinikum der Universität München München
Germany Augenklinik Universitätsmedizin Rostock Rostock
Hungary Elisabeth Academic Hospital Sopron
Spain Hospital Ramon y Cajal Madrid

Sponsors (1)

Lead Sponsor Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of intraocular pressure (IOP) IOP reduction compared after 12 months compared to baseline IOP at 12 Months
Secondary Occurence of Ocular Adverse Events to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery up to 60 Months after surgery
Secondary Reduction of intraocular pressure (IOP) over time IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP at 6, 24, 36, 48 and 60 Months
Secondary Reduction of IOP lowering medication Reduction of IOP lowering medication intake compare to baseline at 6, 12, 24, 36, 48 and 60 Months
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