Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No further use of the divice at our department
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AADI glaucoma shunt | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP | Intraocular pressure before and after surgery | Baseline and after 12 months |
| The change in number of IOP lowering drugs | Number of IOP lowering drugs before and after the surgery | Baseline and after 12 months |
Not provided
Not provided
Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt
Not provided
Not provided
Not provided
Not provided
Observational study, prospective, to evaluate the effect and safety of this new drainage device
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital, Dept. of Ophthalmology | Odense | 5000 | Denmark |
data will be deleted after use, as according to regulation
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2019 | Feb 19, 2019 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided