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

NCT ID: NCT03736655

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2021-10-25

Brief Summary

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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

Detailed Description

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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.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interposition supraciliary implant

Any patients corresponding to inclusion / exclusion criteria

Group Type EXPERIMENTAL

Interposition supraciliary implant

Intervention Type DEVICE

Surgical placement of an interposition supraciliary implant in the supraciliary space

Interventions

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Interposition supraciliary implant

Surgical placement of an interposition supraciliary implant in the supraciliary space

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ciliatech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe SOURDILLE

Role: STUDY_DIRECTOR

Ciliatech

Locations

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Hopital Paris Saint Joseph

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CIV-FR-18-07-024848

Identifier Type: -

Identifier Source: org_study_id