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NCT03850054 Clinical Trial

AADI Glaucoma Shunt - a Quality Control Study

Glaucoma Clinical Trial

Official title:
AADI Glaucoma Shunt - a Quality Control Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03850054
Other study ID # 19/7009
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 4, 2019
Est. completion date September 8, 2021

Study information
Verified date October 2023
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 3
Est. completion date September 8, 2021
Est. primary completion date September 8, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Odense University Hospital, Dept. of Ophthalmology Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in IOP Intraocular pressure before and after surgery Baseline and after 12 months
Primary The change in number of IOP lowering drugs Number of IOP lowering drugs before and after the surgery Baseline and after 12 months
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