AADI Glaucoma Shunt - a Quality Control Study
Conditions: Glaucoma
Sponsor: Odense University Hospital

 
AADI glaucoma shunt – a quality control study 
 
 
 
Project managers: 
Peter Ruhlmann, MD, chief glaucoma surgeon 
Søren Blindbæk, MD 
Anders Vestergaard, MD, PhD, associate professor 
 
Department of Ophthalmology,  
Odense University Hospital 
Sdr. Boulvard 29,  
5000 Odense C 
Denmark 
 
 
Mail: anders.vestergaard@rsyd.dk 
ID No. 19/7009 
Date: February 19th 2019 
 
 

Purpose: 
To investigate the effect and safety of implantation of AADI (Aurolab's Aqueous Drainage Implant) drain on 
eyes with medical intracable glaucoma. 
 
Background: 
Chief physician Peter Ruhlmann (PR), who is responsible for glaucoma tube shunt implantation on 
Department of Ophtahlamlogy, Odense University Hosital (OUH), has over the past 7 years acquired highly 
specialized knowledge from national and international eye departments, and has started the treatment 
methods at OUH in 2011-2012. During this period, the number of annual treatments with glaucoma 
drainage devices has gradually increased, both in Denmark and abroad. There are several different types of 
glaucoma shunts, but in Denmark, two types of devices have been used: Ahmed drainage (with built-in flow 
restrictor in the drain pipe) and Baerveldt drain (without built-in flow restrictor). The Bearveldt drain is 
believed to have a better pressure lowering effect in the longer term than the Ahmed drain, but at the 
expense of a higher complication rate. Chief surgeon PR, is one of two glaucoma surgeons in Denmark with 
the greatest experience in the field of implantation of Baerveldt drainage devices. 
Tube shunt implantation is a relatively expensive treatment method,but may be a good treatment option 
for refractory glaucoma patients where traditional surgery is futile or attempted. In recent years, many new 
forms of drainage have been added, including the AADI drain (Figure 1). This drain is a copy of the original 
Baerveldt drain (with permission from the inventor of the drain, Prof. George Baerveldt) but at a fraction of 
the price. The AADI drain has been commercially available since 2013, initially primarily in India, but has 
now also gained ground on the world's leading eye hospitals, including the Bascom Palmer Eye Institute in 
Miami, the United States, and many European hospitals. The product is approved for Danish conditions, CE 
(Conformité Européene) labeled, and its effects and side effect profile is documented to be at a level 
compared to the Ahmed drain, and can be expected to be equated with the Bearveldt drain. 
 
With this prospective quality control study, we want to investigate the effect and safety after drainage 
implantation with AADI in the period 2019-2020. The project starts from the OUH Eye Department at the 
request of the country's leading glaucoma surgeons. 
 
                                                               Figure 1: Baerveldt and AADI shunts 

 
Methods: 
A prospective quality assessment of all glaucoma patients with an AADI drain in the period 2019-2020 at 
Eye section E, OUH. Patients who would normally be offered Baerveld drainage implantation are instead 
offered the AADI. Pre- and postoperative controls will take place as usual, ie. the patients will have the 
same examinations and controls as for the implantation of Baerveldt and Ahmed drainage devices. Data is 
then transferred to the Oculus glaucoma database, which is a region-based web database with all necessary 
permissions and a high safety profile. The data can then be extracted anonymously or pseudonymised (with 
ID no.) for further analysis and statistics. Patients are followed as usual, up to 1 year postoperatively, and 
possibly up to 2 years after surgery. 
 
The following parameters will be noted: 
- age 
- sex 
- number and type of intraocular pressure lowering eye drops pre- and postoperatively 
- previous laser tools (SLT) or surgery (eg, cataract surgery and trabeculectomy) 
- endothelial cell count pre- and postoperatively 
- Visual Field Index and Mean Defect pre- and postoperatively 
- intraocular pressure pre- and postoperatively 
- pre- and postoperative vision 
- retinal photos pre- and postoperatively including oximetry maps 
- per- and postoperative complications eg. bleeding, hypotension, infection, need for further surgery, 
     progression of glaucoma. 
 
Time schedule: 
The project is expected to start at the end of February. 2019. Data processing is expected to be completed 
by the end of 2022. The results will be presented at national and international glaucoma congresses. 
 
Ethics: 
The project has been approved by the Data Inspectorate (“Datatilsynet”) at Odense University Hospital and 
the Region of Southern Denmark, as a prospective quality assurance and quality development project with 
ID no. 19/7009 . Data will be processed according to the safety requirements for the processing of 
personally identifiable information. 
A written informed consent is sought from the patients prior to the treatment. If patients do not want 
treatment with AADI, as usual, treatment with Bearveldt drainage can be done. 
 
Ref.: 
Oftalmolog dec. 2011, Glaukomdræn. 
Indian J Ophthalmol, 2018 Nov;66(11):1585-1586, Commentary:AADI: New kid on the block. 
Br J Ophtalmol, 2017 Dec;101(12):1623-1627, Safety and efficacy of low-cost glaucoma drainage device for 
refractory childhood glaucom