Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    68
  • sponsor
    Ciliatech
Updated on 2 February 2021

Summary

The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Description

68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Details
Condition Pigmentary glaucoma, Open Angle Glaucoma
Treatment Interposition supraciliary implant
Clinical Study IdentifierNCT03736655
SponsorCiliatech
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of POAG Schafer 3 or 4
Medicated IOP 21

Exclusion Criteria

Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, )
Medical treatment having intraocular hypotensive effect
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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