NCT02825264

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
5 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2016Dec 2026

First Submitted

Initial submission to the registry

June 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

9.4 years

First QC Date

June 20, 2016

Last Update Submit

August 8, 2022

Conditions

Open Angle Glaucoma

Keywords

Glaucoma Drainage DeviceSTARflo

Outcome Measures

Primary Outcomes (1)

  • Reduction of intraocular pressure (IOP)

    IOP reduction compared after 12 months compared to baseline IOP

    at 12 Months

Secondary Outcomes (3)

  • Occurence of Ocular Adverse Events

    up to 60 Months after surgery

  • Reduction of intraocular pressure (IOP) over time

    at 6, 24, 36, 48 and 60 Months

  • Reduction of IOP lowering medication

    at 6, 12, 24, 36, 48 and 60 Months

Study Arms (1)

STARflo

Patients who have been implanted with STARflo implant

Device: STARflo Implant

Interventions

STARflo ImplantDEVICE

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

STARflo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who did not sign a Data Release form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.

Liège, 4000, Belgium

Location

Hospital de la Croix-Rousse

Lyon, 69317, France

Location

CHNO des Quinze-Vingts

Paris, 75571, France

Location

St. Johannes Hospital Dortmund

Dortmund, 44137, Germany

Location

Universitäts-Augenklinik Heidelberg

Heidelberg, 69120, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Augenklinik Universitätsmedizin Rostock

Rostock, 18057, Germany

Location

Elisabeth Academic Hospital

Sopron, 9400, Hungary

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Zubair Hussain, PhD

    Sponsor Representative

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

DE(4)HU(1)BE(1)FR(2)ES(1)