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Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02209961
Collaborator
(none)
100
Enrollment
27
Duration (Months)

Study Details

Study Description

Brief Summary

A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.

    Glaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.

    The Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.

    This study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
    Study Start Date :
    Mar 1, 2014
    Anticipated Primary Completion Date :
    Jun 1, 2015
    Anticipated Study Completion Date :
    Jun 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    glaucoma and ocular hypertension

    glaucoma and ocular hypertension

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract . [within one to two years post surgery]

      to check the change in intraocular pressure after EX-PRESS shunt implantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age above 18
    Exclusion Criteria:
    • congenital glaucoma

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    • Principal Investigator: Rana N Hanna, M.D, Hillel Yaffe Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT02209961
    Other Study ID Numbers:
    • 0054-13
    First Posted:
    Aug 6, 2014
    Last Update Posted:
    Aug 6, 2014
    Last Verified:
    Aug 1, 2014
    Additional relevant MeSH terms:
    Glaucoma
    Cataract
    Ocular Hypertension

    Study Results

    No Results Posted as of Aug 6, 2014