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Trial record 24 of 1614 for:    glaucoma

STARflo European Safety and Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02272569
Recruitment Status : Active, not recruiting
First Posted : October 23, 2014
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Device: STARflo Glaucoma Implant Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: STARflo Glaucoma Implant
Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space
Device: STARflo Glaucoma Implant
Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272569


Locations
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Belgium
UZA
Edegem, Belgium, 2650
CHU Sart Tilman
Liège, Belgium
Bulgaria
MHAT Central Onco Hospital
Plovdiv, Bulgaria
France
Hopital Universitaire de Dijon
Dijon, France, 21000
Hopital de la Croix-Rousse
Lyon, France, 69417
CHNO des Quinze Vingts
Paris, France
Germany
University Clinic Heidelberg
Heidelberg, Germany, 69120
Ludwig-Maximilians-University Munich
Munich, Germany, 80336
Augenklinik Universitatsmedizin Rostock
Rostock, Germany, 18057
Switzerland
Universitatsklinik fur Augenheilkunde Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
iSTAR Medical
Investigators
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Study Chair: Zubair Hussain, PhD Sponsor Representative
Study Director: Sheng Lim, Dr. Medical Advisor

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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT02272569     History of Changes
Other Study ID Numbers: ISM01
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by iSTAR Medical:
glaucoma
glaucoma drainage device
glaucoma shunt

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases