Glaucoma Clinical Trial
Official title:
AADI Glaucoma Shunt - a Quality Control Study
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 |
Verified date | October 2023 |
Source | Odense University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital, Dept. of Ophthalmology | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
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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