AADI Glaucoma Shunt - a Quality Control Study

NCT ID: NCT03850054

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-04

Study Completion Date

2021-09-08

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders H. Vestergaard

MD, PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital, Dept. of Ophthalmology

Odense, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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19/7009

Identifier Type: -

Identifier Source: org_study_id

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