AADI Glaucoma Shunt - a Quality Control Study

Terminated

• Conditions: Glaucoma

• Registration Number: NCT03850054
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-04
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2019-03-04
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IOP	Baseline and after 12 months	Intraocular pressure before and after surgery
The change in number of IOP lowering drugs	Baseline and after 12 months	Number of IOP lowering drugs before and after the surgery

Trial Locations

Locations (1)

Odense University Hospital, Dept. of Ophthalmology; 🇩🇰 Odense, Denmark