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Active, Not Recruiting

NCT Number: NCT02825264

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U., Liège, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STARflo Implant

Device

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

Primary outcomes

  1. Reduction of intraocular pressure (IOP)

    Time frame: at 12 Months

    IOP reduction compared after 12 months compared to baseline IOP

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Jul 7, 2016
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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