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Assessment of Effectiveness Ex-Press Surgery Modification

Primary Purpose

Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Primary Open Angle

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phacoemulsification with implantation of the Ex-Press
deep sclerectomy, phacoemulsification, ExPress implantation
Sponsored by
Military Institute od Medicine National Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale
  • patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic,
  • documented progression of loss of field of vision,
  • significant daily IOP fluctuations,
  • no cooperation from patient with regard to application of anti-glaucoma treatment,
  • allergy to topical medication
  • written consent to involvement and participation in the study for a period of at least 24 months

Exclusion Criteria:

  • no consent to participation in the study
  • prior surgical and laser procedures in the area of the eye
  • narrow- or closed-angle glaucoma
  • post-inflammatory or post-traumatic secondary glaucoma
  • chronic illness of the cornea or optic nerve
  • advanced macular degeneration
  • active inflammatory process
  • pregnancy
  • systemic steroid therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    phaco and Ex-Press

    deep sclerectomy, phaco and Ex-press

    Arm Description

    patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press

    patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation

    Outcomes

    Primary Outcome Measures

    IOP
    the change in level of intraocular pressure
    CDVA
    the change in corrected distance visual acuity
    number of drugs
    the change in number of antiglaucoma medications

    Secondary Outcome Measures

    number of complications
    rate of complications

    Full Information

    First Posted
    January 8, 2019
    Last Updated
    January 14, 2019
    Sponsor
    Military Institute od Medicine National Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03800589
    Brief Title
    Assessment of Effectiveness Ex-Press Surgery Modification
    Official Title
    Comparison of ExPress Implantation Versus Partial Deep Sclerectomy Combined With ExPress Implantation With Simultaneously Phacoemulsification
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2010 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    December 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Military Institute od Medicine National Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to compare the effectiveness and safety profile of ExPress implantation versus partial deep sclerectomy combined with ExPress implantation with simultaneously phacoemulsification.
    Detailed Description
    Mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (DS) with ExPress device implantation. The goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. Mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. Thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (IOP), where vascular factors are largely responsible for the progression of neuropathy. To demonstrate the potential of both types of procedures with the application of the ExPress implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Primary Open Angle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, randomized control study with 24-month follow-up.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    186 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    phaco and Ex-Press
    Arm Type
    Active Comparator
    Arm Description
    patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to phacoemulsification with implantation of the Ex-Press
    Arm Title
    deep sclerectomy, phaco and Ex-press
    Arm Type
    Active Comparator
    Arm Description
    patients with co-existing cataract and glaucoma, qualified to the combined glaucoma surgery according to the protocol which were randomized to deep sclerectomy, phacoemulsification, ExPress implantation
    Intervention Type
    Procedure
    Intervention Name(s)
    phacoemulsification with implantation of the Ex-Press
    Intervention Description
    The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.
    Intervention Type
    Procedure
    Intervention Name(s)
    deep sclerectomy, phacoemulsification, ExPress implantation
    Intervention Description
    The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.
    Primary Outcome Measure Information:
    Title
    IOP
    Description
    the change in level of intraocular pressure
    Time Frame
    baseline, and 24th month after surgery
    Title
    CDVA
    Description
    the change in corrected distance visual acuity
    Time Frame
    baseline, and 24th month after surgery
    Title
    number of drugs
    Description
    the change in number of antiglaucoma medications
    Time Frame
    baseline, and 24th month after surgery
    Secondary Outcome Measure Information:
    Title
    number of complications
    Description
    rate of complications
    Time Frame
    in a day of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), in which a satisfactory IOP level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic, documented progression of loss of field of vision, significant daily IOP fluctuations, no cooperation from patient with regard to application of anti-glaucoma treatment, allergy to topical medication written consent to involvement and participation in the study for a period of at least 24 months Exclusion Criteria: no consent to participation in the study prior surgical and laser procedures in the area of the eye narrow- or closed-angle glaucoma post-inflammatory or post-traumatic secondary glaucoma chronic illness of the cornea or optic nerve advanced macular degeneration active inflammatory process pregnancy systemic steroid therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marek Rękas, Prof
    Organizational Affiliation
    Military Institute of Medicine in Warsaw
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    De-identified individual participant data for all primary and secondary outcome measures will be made available
    IPD Sharing Time Frame
    Data will be available within 18 months of study completion
    IPD Sharing Access Criteria
    Data access requests will be reviewed by the Chair Person. Requestors will be required to sign a Data Access Agreement
    Citations:
    PubMed Identifier
    20552258
    Citation
    Bissig A, Feusier M, Mermoud A, Roy S. Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma. Int Ophthalmol. 2010 Dec;30(6):661-8. doi: 10.1007/s10792-010-9382-z. Epub 2010 Jun 16.
    Results Reference
    result

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