18
DEUTSCH
ENGLISH
FRANÇAIS
ITALIANO
ESPAÑOL
NEDERLANDS
PORTUGUÊS
SVENSKA
© HAAG‑STREIT AG, 3098 Koeniz, Switzerland ‑ HS‑Doc. no. 1500.7220055‑04150 – 2022 – 09
7.4.7 Pupillometry
Measurement range:
2 – 13 mm
Display resolution:
0.01 mm
The above mentioned measurement ranges correspond to the default setting for the automatic ana-
lysis.
The in vivo reproducibility was evaluated in a clinical study of cataract patients (see table 'All eyes'
and table 'Special eyes')
1 σ = One standard deviation
7.4.8 Study design
• The clinical trial for deriving in vivo reproducibility was approved by the local eth-
ics committee. The study was planned and conducted as a prospective, non-
randomised comparative study.
• Two phases were scheduled in the approved study protocol. In the first phase,
measurements of axial length (AL), central corneal thickness (CCT), anterior
chamber depth (ACD), central lens thickness (LT), median corneal radius (R)
and the axis position of the flat meridian (axis) were taken.
• The white-to-white distance (WTW) was measured in the second phase.
• A total of 144 eyes in 80 subjects were included in study phase 1 and a total of
40 eyes in 20 subjects in study phase 2.
• Subjects with different conditions of the anterior and posterior segment of the
eye (cataract in different stages, pseudophakia with different IOLs, aphakia, sil-
icone-oil fill) and subjects with healthy eyes were included in this clinical study.
Data were analyzed for all eyes (see table 'All eyes') and for a subgroup of eyes
with special health conditions (see table 'Special eyes'), with a complete set of 5
repeat measurements on both eyes of each subject.
• The special eyes group included eyes with one or more of the following condi-
tions: pseudophakia, aphakia and silicone-oil fill.
Tab. 1: All eyes
[unit]
n
Mean
grand
SD
repeat
CV
AL [mm]
45 / 90
23.973
0.035
0.00145
CCT [μm]
53 / 106
557.1
2.3
0.00407
ACD [mm]
34 / 68
3.19
0.04
0.01220
LT [mm]
27 / 54
4.56
0.08
0.01784
R [mm]
34 / 68
7.67
0.03
0.00396
Axis [°]
27 / 54
72
11
0.14191
WTW [mm]
9 / 18
12.27
0.04
0.00337
Tab. 2: Special eyes
[unit]
n
Mean
grand
SD
repeat
CV
AL [mm]
10 / 20
24.087
0.056
0.00234
CCT [μm]
11 / 22
564.4
2.8
0.00496
ACD [mm]
5 / 10
7.75
0.03
0.00333
Axis [°]
3 / 6
80
13
0.16092
Abbreviations
n
Number of subjects / number of eyes
Mean
grand
Overall mean of results on all eyes
SD
repeat
Repeatability standard deviation
CV
Coefficient of variation
SD
Standard deviation
LT
Lens thickness
AL
Axial length
R
Corneal radius of curvature
CCT
Central corneal thickness
Axis
Axis of flat meridian
ACD
Anterior chamber depth
WTW
White-to-white distance
