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Trial record 1 of 1410 for:    "glaucoma" OR "early-onset glaucoma"
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AADI Glaucoma Shunt - a Quality Control Study

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ClinicalTrials.gov Identifier: NCT03850054
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Anders H. Vestergaard, Odense University Hospital

Brief Summary:

To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital.

The device will be implanted in eyes instead of the Bearveldt drainage device. Patients and data are prospectively registered to evaluate the effect and safety of the AADI device.


Condition or disease Intervention/treatment
Glaucoma Procedure: AADI glaucoma shunt

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: AADI Glaucoma Shunt - a Quality Control Study
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Procedure: AADI glaucoma shunt

    Implantation of the nonvalved AADI glaucoma shunt instead of the Bearveldt tube shunt, in eyes with intractable glaucoma.

    It is not a RCT study, but a prospective evaluation of the AADI device, and the study has been approved as a quality control study at the Department of Ophthalmology, at Odense University Hospital



Primary Outcome Measures :
  1. Change in IOP [ Time Frame: Baseline and after 12 months ]
    Intraocular pressure before and after surgery

  2. The change in number of IOP lowering drugs [ Time Frame: Baseline and after 12 months ]
    Number of IOP lowering drugs before and after the surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Observational study, prospective, to evaluate the effect and safety of this new drainage device
Criteria
Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850054


Contacts
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Contact: Anders Vestergaard, MD, PhD +45 65412601 anders.vestergaard@rsyd.dk

Locations
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Denmark
Odense University Hospital, Dept. of Ophthalmology Not yet recruiting
Odense, Denmark, 5000
Contact: Peter Ruhlmann, MD       peter.ruhlmann@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
  Study Documents (Full-Text)

Documents provided by Anders H. Vestergaard, Odense University Hospital:
Study Protocol  [PDF] February 19, 2019


Additional Information:

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Responsible Party: Anders H. Vestergaard, MD, PhD, Associate Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03850054     History of Changes
Other Study ID Numbers: 19/7009
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will be deleted after use, as according to regulation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anders H. Vestergaard, Odense University Hospital:
AADI; glaucoma tube shunt

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases