AADI Glaucoma Shunt - a Quality Control Study
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|ClinicalTrials.gov Identifier: NCT03850054|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Glaucoma||Procedure: AADI glaucoma shunt|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||AADI Glaucoma Shunt - a Quality Control Study|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
- 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
- Change in IOP [ Time Frame: Baseline and after 12 months ]Intraocular pressure before and after surgery
- The change in number of IOP lowering drugs [ Time Frame: Baseline and after 12 months ]Number of IOP lowering drugs before and after the surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850054
|Contact: Anders Vestergaard, MD, PhD||+45 email@example.com|
|Odense University Hospital, Dept. of Ophthalmology||Not yet recruiting|
|Odense, Denmark, 5000|
|Contact: Peter Ruhlmann, MD firstname.lastname@example.org|