The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery
Conditions: Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect, Herpetic Keratitis, Angle's Classification, Endothelial Dysfunction
Sponsor: Beyoglu Eye Research and Education Hospital

Document Date: May 24, 2019 
 
 
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The Effect Of Preoperative Parameters On 
Success After Descemet Membrane 
Endothelial Keratoplasty (DMEK) Surgery
CLINICAL STUDY PLAN 
 
 
 

Document Date: May 24, 2019 
 
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ClinicalTrials.gov Results Data Element Definitions 
for Interventional and Observational Studies 
 
 1. Participant Flow 
 
 
 
 
 
 
 
 
 
 
 
Assessed for eligibility (n=  )
 
Excluded  (n=   )
 
Not meeting inclusion criteria (n=  )
 
Declined to participate (n=  )
 
Other reasons (n=  )
 
Analysed   (n=  )
 
Excluded from analysis (give reasons) (n=  )
Lost to follow
 
Discontinued intervention (give reasons) (n=  )
 
Allocated to intervention (n=  )
 Received allocated intervention (n=  )
Did not receive allocated intervention (give
 
reasons) (n=  )
 
 
 
 
Analysis 
Follow Up
 
Enrollment 

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Groups/Cohorts 
Interventions 
Cohort 
             
    All patients 
 
Procedure/Surgery: Descemet 
membrane endothelial keratoplasty 
(DMEK)  
           All participants underwent 
DMEK surgery 
 
Period(s)  
Our study was created by planning a 6-month follow-up period. Information about 
the number of patients at the beginning and end of the study will be reported when 
the study is completed. 
 2. Baseline Characteristics 
 
Patients' age, gender, eye side, additional diseases, medications used and 
preoperative visual acuity values will be recorded at the beginning of the study. 
Groups/Cohorts 
Interventions 
Cohort 
             
    All patients 
 
Procedure/Surgery: Descemet 
membrane endothelial keratoplasty 
(DMEK)  
           All participants underwent 
DMEK surgery 
 
Baseline Analysis Population Information 
Overall Number of Baseline Participants  
A total of 60 participants are planned to participate in the study.  
 
Baseline Measure Information  
Patients' age, gender, eye side, additional diseases, medications used and 
preoperative visual acuity values will be recorded at the beginning of the study. 

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Baseline Measure Title  
The change in the visual acuity and the change in the number of endothelial cells 
will be the primary outcome of the study. 
Study-Specific Measure *§ (Select as many as needed) 
 Age  (Select at least one of the following): 
 Age, Continuous: For example - mean or median age 
 Sex/Gender  (Select at least one of the following): 
 Sex: Female, Male 
 Race and Ethnicity  
 Race and Ethnicity Not Collected 
 
 
 
Measure Type * 
Definition: The type of data for the baseline measure. Select one. 
 Count of Participants 
 
Measure of Dispersion * 
Select one. 
 Not Applicable (only if Measure Type is "Number", "Count of Participants", 
or "Count of Units") 
 
 
Baseline Measure Data * 
When the investigation is completed, information about each baseline measures 
data will be updated. 
Unit of Measure * 
Participants, mmHg, micron, millimeter 
 3. Outcome Measures 
 
A table of data for each primary and secondary outcome measure by arm (that is, 
initial assignment of participants to arms or groups) or comparison group (that is, 

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analysis groups), including the result(s) of scientifically appropriate statistical 
analyses that were performed on the outcome measure data, if any. 
Note: Outcome measure information from the Protocol Section of the record will 
be copied into the Results Section the first time results are created. 
 
Primary Outcome Measure: 
1.Visual Acuity (Snellen) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 
2.Endothelial Cell density (cells/mm2 ) 
After surgery measurements 
[Time Frame: after surgery 1, 3, 6, and 12 months] 
Secondary Outcome Measures: 
1. Maximum (steepest) and minimum (flattest) keratometry values in the 
central corneal zone (K values) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 
2. Anterior chamber depth (mm) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 
3. Axial Length (mm) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 
4. Central pachymetry (micron) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 

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5. Intraocular pressure (mmHg) 
Change from baseline 
[Time Frame: Baseline and after surgery 1, 3, 6, and 12 months] 
Other Pre-specified Outcome Measures: 
6. Surgical complications 
Complications occurring during the surgery will be recorded. 
[Time Frame: During surgery] 
 
 
Groups/Cohorts 
Interventions 
Cohort 
             
    All patients 
 
Procedure/Surgery: Descemet 
membrane endothelial keratoplasty 
(DMEK)  
           All participants underwent 
DMEK surgery 
 
 
Analysis Population Information 
Overall Number of Participants Analyzed  
In total, we expect 60 participants to participate in the study. 
Type of Units Analyzed  
The analysis will be based on participants 
 
Outcome Measure Data Table 
Measure Type  
 Count of Participants 
 
Measure of Dispersion/Precision  

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 95% Confidence Interval 
 
 
Statistical Analyses  
The required sample size was determined by power analysis based on previous 
studies. [G * Power, Version: 3.1.9.2 Statistical Packages]. Variance analysis 
(ANOVA) will be used in the statistical analysis of preoperative and postoperative 
1st and 6th months, if the measurements show normal distribution in the repeated 
measurements. Post-hoc Bonferroni test will be used to find out whether there is a 
difference between the measurements. Friedman test will be used in the statistical 
analysis of measurements that do not show normal distribution. Wilcoxon test will 
be used to find out whether there is a difference between the measurements. 
Pearson and Spearman correlation test will be used in the correlation analysis. For 
statistical significance p <0.05 will be accepted. 
 
 
 4. Adverse Event Information 
 
Information for completing three tables summarizing adverse events. 
1. All-Cause Mortality: Mortality is not expected in our study. 
2. Serious Adverse Events: Serious adverse event is not expected in our study 
3. Other (Not Including Serious) Adverse Events: No adverse effects due to 
study are expected. If any adverse event will be seen, it will be reported. 
Time Frame  
Adverse event data will be collected between 1 June 2019, and 1 June  2021. 
Adverse Event Reporting Description [*] 
Patients will be invited to examinations at regular intervals and will contact the 
researchers at the contact numbers provided if they see any unexpected effects. 
 
 
Collection Approach for Table Default 
 Systematic Assessment: Baseline and after surgery 1, 3, 6, and 12 months 
 
Arm/Group Information  
There is only a study group. 
Arm/Group Title  
All patients 

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Arm/Group Description  
All participants underwent (Descemet membrane endothelial keratoplasty) DMEK 
surgery 
Total Number Affected by All-Cause Mortality 
0 
Total Number at Risk for All-Cause Mortality  
0 
Total Number Affected by Any Serious Adverse Event  
0 
Total Number at Risk for Serious Adverse Events  
0 
 
Frequency Threshold for Reporting Other (Not Including Serious) Adverse 
Events  
5 
 
Total Number Affected by Any Other (Not Including Serious) Adverse Event 
Above the Frequency Threshold  
0 
Total Number at Risk for Other (Not Including Serious) Adverse Events  
0 
 
Adverse Event Term  
A significant unexpected effect that affects the course of the study. 
 
Organ System  
 Eye Disorders 
 
Collection Approach  
 
 Systematic Assessment: Baseline and after surgery 1, 3, 6, and 12 months 
 

Document Date: May 24, 2019 
 
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Number of Participants Affected  
0 
 
Number of Participants at Risk  
0 
 
 5. Limitations and Caveats 
 
Overall Limitations and Caveats 
In our study, only Descemet membrane endothelial keratoplasty (DMEK) surgeries 
were included. However, Descemet's stripping automated endothelial keratoplasty 
(DSAEK) surgeries were not included, and no comparative study was performed.  
 
 6. Certain Agreements 
Information indicating whether there exists an agreement between the sponsor or its 
agent and the principal investigators (unless the sponsor is an employer of the 
principal investigators) that restricts in any manner the ability of the principal 
investigators (PIs), after the completion of the study, to discuss the results of the 
study at a scientific meeting or any other public or private forum, or to publish in a 
scientific or academic journal information concerning the results of the study. This 
does not include an agreement solely to comply with applicable provisions of law 
protecting the privacy of participants. 
 
Are all PIs Employees of Sponsor?  
Definition: Indicate whether the principal investigator is an employee of the 
sponsor. 
 Yes 
 
PI Disclosure Restriction Type 
 
There are no varying agreements. 
 
 7. Results Point of Contact 
 
Point of contact for scientific information about the clinical study results 
information. 

Document Date: May 24, 2019 
 
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Name or Official Title * 
Definition: Dr Semih Çakmak 
 
Organization Name * 
Definition: Beyoglu Eye Research and Education Hospital 
 
Phone: +90 212 2515900 
Extension (Ext.): 351 
 
Email: semihnr@hotmail.com