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TerminatedNCT03736655SAFARIUpdated Dec 20, 2021

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

An interventional study of Interposition supraciliary implant in Glaucoma, Open-Angle, sponsored by Ciliatech. Terminated at 1 site in France. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-12-20.

Sponsored by Ciliatech · Not applicable, Interventional, and Treatment

Why this study was terminated
COVID
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
50 Years to 99 Years
Sex
All
01

Study 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

Read the detailed 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.

02

Conditions studied

  • Glaucoma, Open-Angle
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 27 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Ciliatech is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of POAG Schafer 3 or 4
  • Medicated IOP ≥ 21

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Interposition supraciliary implant

    Any patients corresponding to inclusion / exclusion criteria

    Device: Interposition supraciliary implant

Interventions

  • DeviceInterposition supraciliary implant

    Surgical placement of an interposition supraciliary implant in the supraciliary space

06

What researchers measure

Primary outcomes

  1. Assess post-op IOP reduction

    Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%

    Time frame: 6 months

  2. Assess post-op IOP clinical success

    Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg

    Time frame: 6 months

07

Study locations

1 site
  • Hopital Paris Saint Joseph
    Paris, 75014, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03736655
Lead sponsor
Ciliatech
Responsible party
Sponsor
First posted
Nov 9, 2018
Start date
Mar 15, 2019
Primary completion
Apr 1, 2021
Completion
Oct 25, 2021
Last update
Dec 20, 2021

Study contacts

Philippe SOURDILLE
study director · Ciliatech

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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