search
Back to results

The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

Primary Purpose

Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Neovascular

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ahmed Glaucoma Valve surgery
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
  2. patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.

Exclusion Criteria:

  1. patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits,
  2. patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
  3. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
  4. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.

  5. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    polypropylene plate of Ahmed Glaucoma Valve

    silicone plate of Ahmed Glaucoma Valve

    Arm Description

    polypropylene plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The polypropylene plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.

    silicone plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The silicone plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.

    Outcomes

    Primary Outcome Measures

    the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .
    All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP .

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2019
    Last Updated
    December 30, 2019
    Sponsor
    Ain Shams University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04214847
    Brief Title
    The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases
    Official Title
    One- Year Follow up of Two Models of Ahmed Glaucoma Valves (S2 and FP7) in Refractory Glaucoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2012 (Actual)
    Primary Completion Date
    March 12, 2014 (Actual)
    Study Completion Date
    July 15, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    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 clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.
    Detailed Description
    Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.

    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, Neovascular
    Keywords
    glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    comparing clinical outcome variables (IOP, number of glaucoma medications, visual acuity, and complications) after using S2 and FP7 models of Ahmed Glaucoma Valves.
    Masking
    ParticipantInvestigator
    Masking Description
    Coin test to choice the participants for both groups and reduce bias. Single surgeon ,highly expert in glaucoma to minimize unnecessary postoperative result changes.
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    polypropylene plate of Ahmed Glaucoma Valve
    Arm Type
    Experimental
    Arm Description
    polypropylene plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The polypropylene plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
    Arm Title
    silicone plate of Ahmed Glaucoma Valve
    Arm Type
    Active Comparator
    Arm Description
    silicone plate of Ahmed Glaucoma Valve procedures were performed under local anesthesia except for children, general anesthesia was used. The silicone plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ahmed Glaucoma Valve surgery
    Intervention Description
    The surgical procedure was identical for both implant types and was performed as described previously.9,14 All surgical procedures were performed under local anesthesia except for children, general anesthesia was used. The valve plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
    Primary Outcome Measure Information:
    Title
    the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .
    Description
    All measurements of the postoperative mean IOPs at 12 months were compared with the baseline IOP .
    Time Frame
    one-year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery. patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma. Exclusion Criteria: patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits, patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure. -

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    in ophthalmology department-ophthalmic units-journal club
    Citations:
    PubMed Identifier
    32184556
    Citation
    Elbaklish KH, Gomaa WA. A One-Year Follow-Up of Two Ahmed Glaucoma Valve Models (S2 and FP7) for Refractory Glaucoma: A Prospective Randomized Trial. Clin Ophthalmol. 2020 Mar 4;14:693-705. doi: 10.2147/OPTH.S224653. eCollection 2020.
    Results Reference
    derived

    Learn more about this trial

    The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

    We'll reach out to this number within 24 hrs