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Table 3 Relative frequencies and 95%-confidence interval (95%-CI) relating to the primary and two secondary endpoints, medians and interquartil ranges for the underlying continuous outcome parameter

From: Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority randomized clinical trial (RCT)

 

without CTR (non-CTR sub sample)

with CTR (CTR sub sample)

total (pooled)

Primary endpoint: rotation

n=

72

67

139

 postoperative absolute rotation <= 5 degrees

incidence

89%

91%

90%

95%-CI

81–96%

84–98%

85–95%

 postoperative absolute rotation

median

1.787°

1.722°

1.737°

Interquartile range

0.769°; 3.18°

0.829°; 3.589°

0.801°; 3.372°

Secondary endpoint: cylinder

n=

84

85

169

 absolute postoperative deviation of achieved cylinder from target cylinder ≤ ±0,5 dpt

incidence

45%

46%

46%

95%-CI

34–56%

35–57%

38–54%

 absolute postoperative deviation of achieved cylinder from target cylinder

median [dpt]

0.52

0.55

0.55

Interquartile range [dpt]

0.38; 1.01

0.28; 0.93

0.34; 0.98

Secondary endpoint: BVCA

n=

84

88

172

 CDVA > = 0.8

incidence

92%

88%

90%

95%-CI

86–98%

80–95%

85–94%

 postoperative CDVA

median

1.0

1.0

1.0

Interquartile range

0.8; 1.0

0.875; 1.0

0.8; 1.0

  1. Pooled study sample (Intent-to-treat population), stratified with and without capsular tension ring (CRT)
  2. CDVA: Corrected distance visual acuity
  3. CTR: Capsular tension ring
  4. CI: Confidence Interval
  5. dpt: Dioptre