© HAAG-STREIT AG, 3098 Koeniz, Switzerland – HS-Doc. no. 1500.7220055.04100 – 10. Edition / 2015 – 06
• 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 (cat‑
aract in different stages, pseudophakia with different IOLs, aphakia, silicone-oil ll) and
subjects with healthy eyes were included in this clinical study. Data were analyzed for
all eyes (see Tab. 1) and for a subgroup of eyes with special health conditions (see
Tab. 2), 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 conditions:
pseudophakia, aphakia and silicone-oil ll.
Tab. 1: All Eyes
[unit] n Meangrand SDrepeat 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 Meangrand SDrepeat 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
Coefcient of variation
SD
Standard deviation
LT
Lens thickness
AL
Axial length
R
Corneal radius of curvature
CCT
Central corneal thickness
Axis
Axis of at meridian
ACD
Anterior chamber depth
WTW
White‑to‑white distance
6.5 Technical data of T-Cone (option)
Type designation:
Diameter:
Length:
Weight:
Placido rings:
Covered optical zone:
T‑Cone
ø 84 mm
63.5 mm
0.2 kg
11
≤ 6 mm
6.5.1 Normative considerations
• The T‑Cone complies with the requirements of the ISO 19980:2012 standard for the
central and medial measuring zones; the T‑Cone does not cover the peripheral mea‑
suring zone.
• International standard for ophthalmological instruments.
• Corneal topographer, type B.
• The T‑Cone complies with the requirements of the ANSI Z80.23‑2012 standard for the
central and medial measuring zones; the T‑Cone does not cover the peripheral mea‑
suring zone.
• US national standard for ophthalmological instruments
Corneal topography system, type B.
6.5.2 Measuring accuracy
Test surface (axial curvature difference in mm / elevation difference in µm)
Central zone (Diameter ≤ 3 mm) Middle zone (3 < Diameter ≤ 6 mm)
Mean value
Curvature
diff.
2 st. dev.
Curvature
diff.
2 st. dev.
Elevation
diff.
Mean value
Curvature
diff.
2 st. dev.
Curvature
diff.
2 st. dev.
Elevation
diff.
Toric (mm),
R
1
=7.987,
R
2
=7.584
0.006 0.065 0.66 0.004 0.044 0.33
Ellipsoid (mm),
R=7.79,
k=−0.255
0.001 0.083 0.78 0.020 0.038 1.51
Sphere 1 (mm),
R=6.448
0.013 0.037 0.61 0.012 0.025 1.12
Sphere 2 (mm),
R=7.804
−0.008 0.034 0.33 −0.008 0.026 0.75
01-IFU_LS900-7220055-04100_eng.indd 14 17.06.2015 10:56:02
To Next Page
Loading...