Skip to main content
OpenTrials
Completed

NCT Number: NCT02272569

STARflo European Safety and Efficacy Study

Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.

Completed

Looking for future studies?

Notify Me

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

Interventional

Phase

Not applicable

Primary location

UZA, Edegem, Belgium

Loading trial locations.

About this study

This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.

Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.

When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.

Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.

Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Diagnosis of refractory open angle glaucoma
  • Documented 21 mmHg < IOP ≤ 40 mmHg, under medication
  • Patient must provide written informed consent

Main Exclusion Criteria:

  • Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye
  • Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery
  • Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye

Treatment and study plan

STARflo Glaucoma Implant

Device

Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.

Primary outcomes

  1. Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP

    Time frame: 12 months

    IOP of each patients at baseline will be compared to IOP of patient after 12 months

Secondary outcomes

  1. Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP

    Time frame: 24 months

    IOP of each patients at baseline will be compared to IOP of patient after 24 months

  2. Reduction in number of IOP lowering medications at 12 months vs. baseline

    Time frame: 12 months

    compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months

  3. Reduction in number of IOP lowering medications at 24 months vs. baseline

    Time frame: 24 months

    compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months

  4. Rate of adverse events

    Time frame: 24 months

    assessment and counting of adverse events (% by adverse event) including procedure related complications

  5. Visual Acuity

    Time frame: 12 months

    comparison of visual acuity at 12 months vs. baseline

  6. Absolute success rate (%) at 12 months

    Time frame: 12 months

    absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication

  7. Qualified success rate (%) at 12 months

    Time frame: 12 months

    qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication

  8. Qualified success rate (%) at 24 months

    Time frame: 24 months

    qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication

  9. Absolute success rate (%) at 24 months

    Time frame: 24 months

    absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Oct 23, 2014
Registry last updated
Feb 15, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.