Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
Conditions: Glaucoma
Sponsor: Dietrich-Bonhoeffer-Klinikum

Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
                                                                                                                                                      
 
 
 
 
 
 
The CyPass-Stent  
 
 
 
 
 
 
PROTOCOL 
Version II 
(08/07/2018) 
 
 
Retrospective and prospective, monocentric study to 
evaluate the 5-year results of safety and efficacy 
following CyPass-stent implantation  
 
 
 
 
 
 
 
Sponsor: 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
Salvador-Allende-Straße 30, 
17036 Neubrandenburg 
Germany 
Phone: +49 335 775-0 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
2 
 
 
PROTCOL 
Version II 
 
Retrospective and prospective, monocentric study to 
evaluate the 5-year results of safety and efficacy 
following CyPass-stent implantation 
 
 
Subject  
The Safety and efficacy of the supraciliary CyPass microstent five 
years postoperatively. 
 
Sponsor 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
Salvador-Allende-Straße 30, 
17036 Neubrandenburg 
Germany 
Tel: +49 395 775-0 
 
Principal  
    
Prof. Dr. med. Helmut Höh 
Investigator  
Head of the department of Ophthalmology 
 
 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
 
 
 
Salvador-Allende-Straße 30, 17036 Neubrandenburg 
Tel: +49 395/775-3469, Fax: +49 395/775-3468,  
HelmutHoeh@online.de  
 
Sub    
 
Ahmed Medra 
Investigator  
Physician at the Department of Ophthalmology 
 
 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
 
 
 
Salvador-Allende-Straße 30, 17036 Neubrandenburg 
 
 
 
Tel: +49 395/775-3474, Fax: +49 395/775-3468,  
MedraA@dbknb.de  
 
Assistant 
 
Ulrike Holland 
 
 
 
Head of research center of ophthalmology 
 
 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
 
 
 
Salvador-Allende-Straße 30, 17036 Neubrandenburg 
 
 
 
Tel: +49 395/775-3427, Fax: +49 395/775-3468,  
aug-st2@dbknb.de 
 
Institution  
Department of Ophthalmology 
 
 
 
Diakonie Klinikum Dietrich Bonhoeffer GmbH 
 
 
 
Salvador-Allende-Straße 30, 17036 Neubrandenburg 
 
 
 
CEO: Gudrun Kappich 
 
 
 
 
 
 
 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
3 
Table of content 
 
1. 
BACKGROUND ............................................................................................. 4 
2. 
SYNOPSIS .................................................................................................. 4 
2.1 
Study objective .................................................................................... 4 
2.2 
Study population .................................................................................. 4 
2.1.1  Inclusion criteria .................................................................................. 5 
2.1.2  Exclusion criteria ................................................................................. 5 
2.3 
Study design ........................................................................................ 5 
2.4 
Study investigation plan ........................................................................ 5 
2.5 
Safety relevant results........................................................................... 6 
2.6 
Success of the treatment ....................................................................... 6 
2.7 
Sample size calculation .......................................................................... 6 
3. 
OBSERVATION PERIOD ................................................................................ 7 
4. 
Procedure ................................................................................................... 7 
4.1 
Screening ............................................................................................ 7 
4.2 
Patient recruitment ............................................................................... 7 
4.3 
Patient pseudonymization ...................................................................... 7 
4.4 
Documentation ..................................................................................... 7 
4.5 
Postoperative data collection .................................................................. 7 
5. 
STATISTICAL EVALUATION ..........................................................................10 
6. 
ETHICAL ASPECTS ......................................................................................10 
7. 
SAFETY .....................................................................................................10 
8. 
SIGNATURE OF THE PRINCIPAL INVESTIGATOR .............................................11 
9. 
LITERATURE ..............................................................................................11 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
4 
1. 
BACKGROUND  
 
In industrial countries worldwide and in Germany, glaucoma is the second most common 
cause of blindness. Glaucoma therapy with eye drops is the first line therapy. To achieve 
the target IOP (intraocular pressure) nearly half of the glaucoma patients require topical 
antiglaucomatous therapy with multiple drugs and different dosages. Therefore a 
consequent patient adherence is needed. With an adherence of only about 50% after one 
year of treatment, this is not sufficiently guaranteed. The resulting undertherapy may 
contribute to the progression of glaucoma damage. Therefore, surgical reduction of the 
intraocular pressure (IOP) is increasingly becoming an option for reducing topical 
therapy. The CyPass stent was developed as a less complicated surgical alternative to 
trabeculectomy. 
 
We have been implanting the CyPass microstent at the Department of Ophthalmology in 
Neubrandenburg as a surgical glaucoma treatment procedure since 2009.  
 
Since there is a negative pressure difference between the suprachoroidal space and the 
anterior chamber, the supraciliary CyPass microstent improves aqueous humor drainage 
into the suprachoroidal space. 
 
In literature, we can only find follow-up data up to 2 years postoperatively for ’single’ 
CyPass surgery [1, 2, and 3]. Long-term data are not yet available. 
 
2. 
SYNOPSIS 
 
2.1 
Study objective 
 
We designed this study to assess the long-term outcome after implantation of the 
supraciliary CyPass microstent beyond two years. The long-term results are of 
considerable importance for the evaluation and positioning of the CyPass stent procedure 
in the surgical glaucoma treatment armamentarium. We will collect data of a follow-up 
period of an average of 5 years. 
 
The main research outcome is the determination of the efficacy of CyPass microstent 
implantation 
in 
reducing 
the 
intraocular 
pressure, 
the 
number 
of 
necessary 
antiglaucomatous medications and the progression of glaucoma in terms of visual field 
worsening and progression of glaucomatous optic disc changes. 
 
Another main outcome is the safety of the procedure based on the intraoperative and 
postoperative complications. 
 
Secondary outcomes include the development of the stent-associated blebs, the long-
term success rate of the CyPass stent, and the clinical identification of stent failures. 
 
2.2 
Study population 
 
 
We plan to examine at least 84 eyes. Therefore, we invite patients with at least 
130 study eyes (see sample size calculation 2.7). 
 
All patients after implantation of a CyPass microstent on at least one eye. 
Excluded are patients which had combined operation (phacoemulsification with 
intraocular lens implantation and CyPass stent implantation) 
 
We will not invite the patients of whom we already have the long-term data 
available because they had been examined in the past at the department of 
Ophthalmology. We will take the available data from the medical records. 
 
Patients with secondary surgery due to CyPass failure will not be invited for the 
examination. We will collect the available data up to the date of the new operation 
from the patient’s records and classify these cases as failure. 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
5 
 
The following inclusion and exclusion criteria are considered for the prospective 
part of the study: 
 
2.1.1 Inclusion criteria 
 
- 
Patients 3 to 8 years following implantation of a CyPass-Stent between 2009 
and 2014 
- 
Willingness of patients to participate in the study and signing the written 
informed consent 
 
2.1.2 Exclusion criteria 
 
- 
Patients who live far away or with limited health conditions, to whom the trip 
to Neubrandenburg cannot reasonably be expected. 
- 
Patients who moved to an unknown address. 
- 
Deceased patients (with evaluation of the existing data). 
- 
Patients who are not interested in participating in the study. 
 
2.3 
Study design 
 
Monocentric study with two parts: 
 
Retrospective part: Collection of preoperative, intraoperative and postoperative 
data from the medical records 
 
Prospective part: Inviting patients according to inclusion and exclusion criteria for 
a single examination and collection of postoperative data after an average of five 
years 
 
2.4 
Study investigation plan 
 
The pre- and intraoperative data, the data of the routine follow-up after 3 and 6 months 
postoperatively, as well as data of unscheduled examinations are taken retrospectively 
from the patient files. 
 
 
Collection of preoperative findings from the medical record: 
 
i. 
Patient name, date of birth, gender, operated eye and surgery date 
ii. 
General diseases and medications 
iii. 
Eye diseases and already performed eye operations, if any 
iv. 
Best corrected visual acuity 
v. 
Topical and systemic glaucoma therapy and duration of glaucoma 
therapy 
vi. 
Time of diagnosis of glaucoma, if available 
vii. 
Intraocular 
pressure 
using 
Goldmann 
tonometer 
and 
time 
of  
measurement 
viii. 
Central corneal thickness and pachymetric correction factor measured 
with the ultrasonic pachymeter or with Visante-OCT. 
ix. 
Classification of the chamber angle width according to Shaffer 
classification  
x. 
The lens condition or existing opacities of the natural lens or presence of 
an implanted intraocular lens at the time of surgery 
xi. 
Visual field using Humphrey perimeter or TAP (Tuebinger automatic 
perimeter) 
xii. 
Optic nerve configuration measured with the HRT-II (Heidelberg Retina 
Tomograph II) 
xiii. 
Retinal nerve fiber layer thickness measured with Stratus OCT 
 
 
Collection of intraoperative characteristics or complications from the surgical 
report 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
6 
 
Collection of available postoperative findings and complications 
 
A written or telephone invitation of the patients to a postoperative examination in 
the Department of Ophthalmology Neubrandenburg to collect the current, long-
term postoperative findings 
 
The following examinations are performed during the study visit 5 years 
postoperatively: 
 
i. 
Ophthalmic history 
ii. 
Best corrected visual acuity 
iii. 
Topical and possibly systemic glaucoma therapy 
iv. 
Intraocular pressure using Goldmann tonometer 
v. 
Central corneal thickness and the pachymetric correction factor 
measured with the ultrasonic pachymeter or with the Visante-OCT 
vi. 
Visual field using Humphrey perimeter 
vii. 
Gonioscopic findings 
viii. 
The lens condition or opacities of the natural lens or of the implanted 
intraocular lens 
ix. 
Optic nerve configuration measured with the HRT-II (Heidelberg Retina 
Tomograph II) 
x. 
Nerve fiber thickness measured with Stratus OCT 
xi. 
Imaging and evaluation of the CyPass stent and associated bleb with the 
help of Visante-OCT/UBM (Ultrasound Biomicroskopy) 
 
2.5 
Safety relevant results 
 
 
Occurrence of accidents on the way from home to Neubrandenburg or the other 
way back and adverse events during the examination at the Clinic for 
Ophthalmology Neubrandenburg 
 
2.6 
Success of the treatment 
 
We use two classifications to define treatment success: 
 
The first classification: dividing patients into 2 groups according to the need for 
postoperative glaucomatous medication: with and without medication. Then we 
divide each group into 4 subgroups according to the postoperative intraocular 
pressure achieved: patients with IOP >21mmHg, patients with IOP ≤21mmHg and 
>18mmHg, patients with IOP ≤18mmHg and >15mmHg, and patients with IOP 
≤15mmHg. 
 
The second classification: definition of the treatment success according to the 
criteria of WGA (World Glaucoma Association) [4]. Complete success is achieved if 
the target IOP is reached without additional medication. Achieving the target 
pressure with additional local therapy is rated as qualified success. The loss of 
visual acuity to ‘nulla lux’ because of glaucoma progression, the need for systemic 
therapy with CAI (carbonic anhydrase inhibitor) to reduce pressure or the need for 
second glaucoma surgery are classified as complete failures. 
 
2.7 
Sample size calculation 
 
We calculate the sample size by using the following formula [5]: 
 
  
𝑛= 21 ∙𝜎2
𝑑2 = 21 ∙82
42 ≈84 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠 
 
[n= number of subjects   σ = standard deviation    𝒅 = relevant difference   α= 0,05   β=0,10] [6] 
 
With a follow-up period of 5 years on average, we expect a response rate of 65%. 
Therefore the sample size will be 130 (n = 84 / 0.65 ≈ 130 patients) 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
7 
3. 
OBSERVATION PERIOD 
 
All patients potentially taking part in the study were treated with a CyPass micro-stent at 
the Department of Ophthalmology in Neubrandenburg between 2009 and 2014. Thus, we 
know the exact date of operation. 
 
The duration of the observation period for each patient depends on the duration of the 
postoperative period up to the last follow-up visit in the Department of Ophthalmology 
Neubrandenburg in the context of the study. With follow-up visits, scheduled for the 
second half of 2016, we expect an average follow-up of more than five years.  
 
4. 
Procedure  
 
4.1 
Screening 
 
All patients who underwent CyPass microstent implantation without combination with 
cataract surgery, in the period between 2009 and the end of 2014 are potential 
candidates for the study. The selection of patients takes place according to the inclusion 
and exclusion criteria. Once a patient has met the criteria described above, we inform 
him in written form or by telephone about the study and ask him to participate. 
 
4.2 
Patient recruitment 
 
The patient participates in the study when he fulfils the inclusion and exclusion criteria 
based on the findings and when he has signed the inform consent. We take out a 
proband insurance and travel insurance before the start of the study. 
 
4.3 
Patient pseudonymisation 
 
After completion of the data collection, every patient record is provided with a unique 
patient identification code (pseudonymisation). This code is for study purposes only. 
After data collection, only the study physician and the study assistant can identify the 
patient. 
 
4.4 
Documentation 
 
The data will be collected first via a data collection form (Appendix 1) and then via the 
Excel program. We collect the intraoperative information from the surgical documentation 
books, the surgical reports and the patient medical records. 
o 
Surgery-Date 
o 
Patient Name, date of birth, gender and address of the patient 
o 
Operated eye (OD/OS) 
o 
Anesthesia 
o 
Intraoperative course, peculiarities or complications 
o 
Preoperative findings 
o 
Postoperative findings 
 
4.5 
Postoperative data collection 
 
We collect the following data prospectively (at the five-year follow-up visit): 
i. 
Intermediate history: First, asking the patients about the postoperative 
course and the regular check-ups at the registered ophthalmologist. If 
available, taking the intermediate eye pressure values and the course of 
the topical therapy, which may have been documented by the Glaucoma 
pass. Documentation of events such as bleeding or acute IOP-increase. 
Also documentation of intermediate treatments with date, if any, such as 
laser treatments. 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
8 
 
ii. 
Intraocular pressure: Measuring the intraocular pressure twice in a row 
using a properly calibrated Goldmann tonometer (Carl Zeiss Meditec, Jena, 
Germany). The measurements should take place at the same time (± 1 
hour) as preoperatively. Documentation of the average value of both 
measurements is required. If there is a difference of more than three 
mmHg between these two measurements, a third measurement is taken 
and the average of all three measurements is documented. The physican 
doctor measure the intraocular pressure and the assistant reads it. 
The target pressure is determined according to the criteria of WGA (World 
Glaucoma Association) [7]. We initially classify the patients into three 
groups according to visual field damage (mean deviation): 
 
mild damage (> -5 dB to -10 dB): target IOP ≤ 21mmHg and IOP 
reduction ≥ 20%  
 
moderate damage (> -10 dB to -15 dB): target IOP ≤ 18mmHg and 
IOP reduction ≥ 30%  
 
severe damage (>-15 dB): target IOP ≤ 15mmHg and IOP 
reduction ≥ 40% 
iii. 
Central corneal thickness: A corneal topography is performed using Visante 
OCT (Model: 1000, Carl Zeiss Meditec, Jena, Germany). We define the 
thinnest part of the cornea as central corneal thickness. Alternatively, if 
the Visante OCT topography is not available (e.g., blepharospasm), three 
measurements are taken by means of an ultrasonic pachymeter (OcuScan, 
Alcon, Fort Worth, Texas, USA) to determine the central corneal thickness. 
The average of these three measurements is considered central corneal 
thickness. 
 
iv. 
Visual field: The visual field examination is performed by using the 
Humphrey Perimeter (Humphrey Field Analyzer, Model 720i, Carl Zeiss 
Meditec, Jena, Germany) with threshold test centrally 24-2. The visual field 
is evaluated with the help of the MD value and the PSD value. The rate of 
progression is expressed in the form of dB / year [8]. As a significant 
clinical change (improvement or worsening), MD values of ≥ 3 decibels are 
assessed [9]. In addition, the visual field defects in the central 5-degree 
visual field are counted in all four quadrants (4 visual field points in total) 
and evaluated as follows: points with sensitivity level > 10 dB are 
classified with 0 point, while the points with ≤ 10 dB are evaluated with 1 
point. The points are added and then divided by 4. Thus, in the evaluation, 
the normal regular central visual field will be rated with 0 and the 
advanced central scotoma in all four quadrants is rated as 1.0. 
 
v. 
Glaucoma therapy: Number and name of the active ingredients of the 
prescribed 
topical 
and 
systemic 
antiglaucomatous 
medications 
preoperatively and at follow-up visits are assessed. The duration of the 
postoperative drug-free phase is documented. The systemic intake of 
acetazolamide (carbonic anhydrase inhibitor) is documented separately 
and evaluated as absolute failure. 
 
vi. 
Visual acuity: First, the refraction is measured with an auto refractometer 
(KR-800S, Topcon, Tokyo, Japan). The best-corrected visual acuity is 
checked and adjusted with the best possible correction using Snellen chart. 
For the statistical evaluation, a visual acuity of hand motion is documented 
as 1/800, light perception as 1/1600, and Nulla-lux as 1/3200 [10]. 
 
vii. 
The optic disc change: Pre- and postoperative optic disc measurement is 
performed using the HRT II (Heidelberg Retina Tomograph II, Heidelberg 
Engineering GmbH, Heidelberg, Germany). The area of the optic disc and 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
9 
the course of the rim area changes are documented and evaluated. 
Furthermore, the disc change is assessed and evaluated with the help of 
MRA (Moorfields Regression Analysis). The entire disc area is divided into 6 
segments. First, the green segments lying within the standard range are 
rated with 0 points. The borderline yellow segments are scored 1 point and 
the pathologic red segments are scored with 2 points. The total number of 
points is added and then divided by 12. That means the normal non-
glaucomatous papilla is rated with 0, the optic disc with terminal damage 
by glaucoma in all segments rated with 1.0. 
 
viii. 
The nerve fiber layer: A measurement of the thickness of the peripapillary 
nerve fiber layer is carried out by the Stratus OCT (Model 3000, Carl Zeiss 
Meditec, Jena, Germany). The evaluation of nerve fibers is performed 
according to the number of damaged segments and the extent of damage 
of each segment. Each measurement results in 12 segments. The healthy 
segments (shown in green) are classified with 0 points, the moderately 
damaged segments (shown in yellow) are classified with 1 point and the 
markedly damaged segments in red are classified with 2 points. The total 
number of points is added and divided by 12, resulting in an average 
number of evaluable segments. The numbers of non-evaluable segments 
(shown in white), if any, are subtracted from the 12 segments and the 
total score is then divided by the number of segments that can be 
evaluated. 
 
ix. 
Description of the CyPass stent and the bleb: By using the Visante OCT 
(Model: 1000, Carl Zeiss Meditec, Jena, Germany) the stent and the stent-
associated bleb are morphologically visualized. It is assessed if the stent 
lumen is clear or if there is a CyPass occlusion. The size of the bleb is 
assessed and classified morphologically into 4 groups. While the largest 
bleb is assessed with 3 points, the absence of the bleb is rated with 0 
points. 
 
x. 
Position of the stent: The stent position is assessed by a gonioscopic 
examination of the angle of the anterior chamber with the Goldmann 
goniolens. Possible iris tissue growing and anomalies of the neighboring 
tissue (goniosynechiae) are documented as follows: 
 If there are no synechiae, it is classified with 0 points. 
 Goniosynechiae around the stent but without collar or lumen 
involvement are classified with 1 point. 
 Collar and / or lumen involvement of goniosynechiae is classified as 
2 points. 
 Completely overgrowed and closed CyPass stent is classified with 3 
points. 
 
The depth of CyPass implantation is also assessed and documented using 
the number of visible rings. If the stent is not visible, it is rated with 0 
points, if only the collar is visible, it is rated with 0.5 points. Depending on 
the number of rings visible, 1 to 3 points (one point per ring) are given. 
 
New findings will be added to the data collection table in the Excel program. 
 
 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
10 
5. 
STATISTICAL EVALUATION 
 
For data protection reasons, all data of a patient are immediately pseudonymised after 
completing the data collection. The study assistant ensures that it is no longer possible to 
draw any conclusions about the respective patient from the data collected. 
 
The data is statistically evaluated with the computer program STATISTICA (Version 10, 
StatSoft GmbH, Hamburg, Germany) using adequate statistical procedures. 
 
Classification 
of 
the 
Follow-up-Visits 
according 
to 
the 
examination 
timeframe 
recommended by the WGA (World Glaucoma Association) [11]: 
 
 
D1 
W1 
M1 
M3 
M6 
M12 
M18 
M24 
M36 
Ideal 
1 day 
7 days 
28-31 
days 
90-92 
days 
181-183 
days 
yearly 
Date 
547-548 
days 
yearly 
Date 
yearly 
Date 
Preferred 
1-2 days 
4-11 days 
21-42 
days 
77-106 
days 
161-204 
days 
334-387 
days 
486-609 
days 
669-822 
days 
±91 days 
Acceptable 
1-3 days 
4-14 days 
15-60 
days 
61-122 
days 
123-272 
days 
273-456 
days 
457-639 
days 
640-913 
days 
± 181 
days 
 
6. 
ETHICAL ASPECTS 
 
Prior to the start of the study, a vote will be obtained from the Greifswald Ethics 
Committee and the responsible supervisory authority according to the local law, 
regulations and authorities. 
 
7. 
SAFETY 
   
Since this is a retrospective and prospective data collection, rather than a clinical 
interventional trail, possible adverse events are limited to possible travel accidents and 
possible complications of the final follow-up visit, such as a conjunctival irritation, 
subjective impairment because of the pupil dilation or in very rare cases and corneal 
erosion after the measurement of the IOP or after gonioscopy. For the patients travelling 
to the examination, travel insurance and a proband insurance is taken out for the 
possible complications caused by the investigations. In case of conjunctival irritation, tear 
substitutes will be provided free of charge. In the very rare event of a corneal injury, tear 
substitutes and antibiotic-containing eye drops will be provided free of charge. 
 

Protocol Version II 
5-year CyPass results 
Retrospective and prospective, monocentric study to evaluate the 5-year results after CyPass-stent implantation regarding 
safety and efficacy  
11 
8. 
SIGNATURE OF THE PRINCIPAL INVESTIGATOR 
 
I have read the study procedures described in this protocol and I agree to comply with 
them. 
 
 
 
Prof. Dr. med. Helmut Höh 
Principal Investigator 
 
 
 
 
 
 
 
Date, 
Signature 
 
 
 
 
Ahmed Medra 
Sub-Iinvestigator 
 
 
 
 
 
 
 
Date, Signature 
 
 
 
 
Ulrike Holland 
Head of the research center  
 
 
 
 
 
Date, Signature 
 
 
9. 
LITERATURE 
 
[1]  H. Höh, S. Grisanti, M. Rau und S. Ianchulev, „Zwei Jahre klinische Erfahrungen mit dem CyPass-
Mikrostent: Sicherheit und operative Erebnisse eines neuen suprachorioidalen Mikrostents,“ Klinische 
Monatsblätter für Augenheilkunde 2014; 231(4): S. 377-381.  
[2]  H. Höh, S. Grisanti, S. D. Vold, A. Anton, M. Rau, K. Singh, D. F .Chang, B. J. Shingleton, S. Grisanti und 
T. Ianchulev, „Initial clinical experience with the CyPass Micro-Stent: safety and surgical outcomes of a 
novel supraciliary microstent,“ Journal of glaucoma, 2016, 25. Jg., Nr. 1, S. 106-112.  
[3]  J. García-Feijoo, M. Rau, S. Grisanti, H. Höh, C. Erb, P. Guguchkova, I. Ahmed, G. Grabner, H. Reitsamer, 
T. Shaarawy und T. Lanchulev, „Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing 
Topical Therapy: 1-Year Results of a Multicenter Study,“ American Journal of Ophthlamology 2015; 159 
(6): S. 1075 - 1081.  
[4]  T. Shaarawy, F. Grehn und M. Sherwood, Guidelines on Design and Reporting of Glaucoma Surgical Trials, 
Amsterdam: Kugler Publications, 2009, S. 17.  
[5]  M. Kutschmann, R. Bender, U. Grouven und G. Berg, „Aspekte der Fallzahlkalkulation und 
Powerberechnung anhand von Beispielen aus der rehabilitationswissenschaftlichen Forschung 
Rehabilitation,“ Rehabilitation, Bd. 45, pp. 377-384, 2006.  
[6]  P. M. David C Musch, M. Paul R Lichter, M. Kenneth E Guire, C. Carol L Standardi (RN und T. C. S. Group, 
„The collaborative initial glaucoma treatment study,“ Ophthalmology, Bd. 106, Nr. 4, pp. 653-662, 1999.  
[7]  T. Shaarawy, F. Grehn und M. Sherwood, Guidelines on Design and Reporting of Glaucoma Surgical Trials, 
Amsterdam: Kugler Publications, 2009, S. 17, 18.  
[8]  European Glaucoma Society, Terminologie und Leitlinien für das Glaukom, IV Hrsg., PubliComm, 2015, S. 
64.  
[9]  European Glaucoma Society, Terminologie und Leitlinien für das Glaukom, IV Hrsg., PubliComm, 2015, S. 
18.  
[10] T. Shaarawy, F. Grehn und M. Sherwood, Guidelines on Design and Reporting of Glaucoma Surgical Trials, 
Amsterdam: Kugler Publications, 2009, S. 22.  
[11] T. Shaarawy, F. Grehn und M. Sherwood, Guidelines on Design and Reporting of Glaucoma Surgical Trials, 
Amsterdam: Kugler Publications, 2009, S. 23, 79, 80.