AADI Glaucoma Shunt - a Quality Control Study

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03850054

Enrollment

Registered

2019-02-21

Start date

2019-03-04

Completion date

2021-09-08

Last updated

2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

AADI; glaucoma tube shunt

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.

Interventions

PROCEDUREAADI 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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026