Genetic and Risk Factors in Exfoliation Glaucoma Patients in Sweden
Conditions: Glaucoma Capsulare, Genetic Predisposition to Disease, Risk Reduction
Sponsor: Göteborg University

1 
 
Cover Page 
 
Study Protocol  
 
Project title: Genetic and risk factors in exfoliation glaucoma (Glaugene) 
 
NCT: N.A.  
 
Date of approval: 2012, May 6.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
Summary and variable explanations 
 
Project: Genetic and risk factors in exfoliation glaucoma (Glaugene) 
 
Variables at inclusion:  
1) Age: measured in years 
2) Sex: female/male 
3) Visual acuity: measured in Snellen’s units (0.1-1.0) 
4) Intraocular pressure (IOP): measured in mmHg, measured with applanation tonometer.  
5) Central corneal thickness (CCT): measured with OCT, measured in µm 
6) Visual field: performed using a Humphrey device, software 24-2 (SITA-fast). The 
variables included in the study are the mean deviation (MD) and the visual field index 
(VFI).  The MD measured in dB, and the VFI measured in %.  
7) Gonioscopy: performed in dark rum, classified the angle in 4-0 and pigmentation in 3-
0.  
8) The cup/disc ratio (CD ratio), measured with a 90-lins after dilation.  
9) Cataract status measured as patient cataract operated or not (Yes/No).  
10)  Presence of glaucoma in one or both eyes.  
11)  Presence of exfoliation, measured after dilation. Classified as Yes/No.  
12)  Treatment with IOP lowering eye-drops: measured as the number of medicines and 
not the number of bottles.  
13)  Laser (SLT) treatment: measured as Yes/No.  
14)  At inclusion patients answered a questionnaire with several questions like how long 
they had glaucoma, diabetes, hypertension, smoking, family history for glaucoma, use 
of medicines, other eye diseases and other general diseases. Please see the 
questionnaire in a separate file.  
15) Genetics were evaluated as allele’s frequencies of the LOXL1_SNPs. Genetic analysis 
was performed at LGC Genomics (Hoddesdon, Herts, UK) using competitive allele-
specific PCR (KASP) genotyping. 
 
Variables at follow-up (three years) tested every six months:  
1) Visual acuity: as above, see 3) 
2) The IOP: as above see 4) 
3) The visual field (MD and VFI), as above see 6) 
4) Cataract operation: as above, see 9) 
5) Number of medications: as above, see 12) 
6) Laser treatment (SLT), as above, see 13) 
 
 
 

3 
 
 
 
Study Protocol 
Inclusion 
 
Patients’ ID:  
 
 
 
 
 
 
 
Protocol number:  
Name and surname:  
Date:  
Age:  
Sex:  
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
CCT 
 
 
 
VF-MD 
 
 
 
VF-VFI 
 
 
 
Gonioscopy-angle 
 
 
 
Gonioscopy-pigment 
 
 
 
C/D Ratio 
 
 
 
Cataract operation 
 
 
 
Glaucoma 
 
 
 
Exfoliation 
 
 
 
Eye-drops 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 

4 
 
 
 
 
6 months Check-up 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

5 
 
 
 
 
 
 
12 Months Check-up 
 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 
 
 
 
 
 
 
 
 
 

6 
 
 
 
 
 
 
 
18 Months Check-up 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 
 
 
 
 
 
 
 
 
 

7 
 
 
 
 
 
 
 
24 Months Check-up 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 
 
 
 
 
 
 
 
 
 

8 
 
 
 
 
 
 
 
30 Months Check-up 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information:  
 
 
 
 
 
 
 
 
 
 
 

9 
 
 
 
 
 
 
36 Months Check-up 
 
 
 
 
 
Right 
 
Left 
Visual acuity 
 
 
 
IOP 
 
 
 
Visual field-MD 
 
 
 
Visual-field-VFI 
 
 
 
Cataract operation 
 
 
 
Number of medications 
 
 
 
SLT 
 
 
 
 
Additional information: