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Table 5 Intra-group and inter-group comparison of CMT during the treatment period

From: Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial

Data set

 

Change in CMT (μm; mean ± SD)

Visit 1 → Visit 5

Visit 5 → Visit 14

Visit 1 → Visit 14

ITT

IVOM

−90.33 ± 114.65 (p = 0.046)

20.43 ± 79.61 (p = 0.523)

− 104.86 ± 68.76 (p = 0.007)

IVOM+Laser

− 107.80 ± 56.24 (p < 0.001)

−16.70 ± 62.96 (p = 0.423)

− 124.50 ± 81.08 (p = 0.001)

IVOM vs. IVOM+Laser

p = 0.673

p = 0.299

p = 0.609

PPS

IVOM

− 94.25 ± 77.47 (p = 0.093)

29.00 ± 34.28 (p = 0.189)

−65.25 ± 67.57 (p = 0.149)

IVOM+aser

−99.13 ± 50.55 (p = 0.001)

−18.25 ± 71.21 (p = 0.492)

− 117.38 ± 82.71 (p = 0.005)

IVOM vs. IVOM+Laser

p = 0.897

p = 0.245

p = 0.304

  1. ITT intent-to-treat set (all randomized subjects); PPS per-protocol set (subjects with complete data of primary and secondary target variables at the first and last visit, with no major protocol deviations); CMT central macular thickness;
  2. Comparisons between groups were done using Student’s t-test for dependent samples.