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SAFARI FU: Study of an Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

Sponsor
Ciliatech (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05159817
Collaborator
(none)
19
Enrollment
1
Location
36.5
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to prolong observational follow-up up to 36 months of patients already implanted with a novel interposition supraciliary implant.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    19 patients with primary open angle glaucoma (POAG) refractory to topical medical therapy were operated in late 2020 and a novel interposition supraciliary device implanted.

    These patients reached 6 months follow-up and the original study had to be interrupted.

    This observational study prolonges follow-up to 36 months

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    19 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Monocentre, Observational Clinical Study Evaluating the Efficacy and Safety of a Novel Interposition Supraciliary Implant in Glaucoma Surgery
    Actual Study Start Date :
    Dec 15, 2021
    Anticipated Primary Completion Date :
    Feb 28, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Assess post-op IOP reduction [12, 24 and 36 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients who were implanted in this center with the novel supraciliary interposition device under the scope of clinical trial NCT03736655
    Exclusion Criteria:
    • if cannot assist to all future follow-up visits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Malayan Center Yerevan Armenia 0033

    Sponsors and Collaborators

    • Ciliatech

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ciliatech
    ClinicalTrials.gov Identifier:
    NCT05159817
    Other Study ID Numbers:
    • SAFARI FU
    First Posted:
    Dec 16, 2021
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Jan 18, 2022