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Table 4 Intra-group and inter-group comparison of BCVA during the study 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

Dataset

 

Change in BCVA (mean ± SD)

Visit 1 → Visit 5

Visit 5 → Visit 14

Visit 1 → Visit 14

ITT

IVOM

4.11 ± 6.31 (p = 0.087)

2.86 ± 5.08 (p = 0.187)

5.86 ± 1.86 (p < 0.001)

IVOM+Laser

4.30 ± 6.96 (p = 0.083)

5.00 ± 4.74 (p = 0.009)

9.30 ± 5.12 (p < 0.001)

IVOM vs. IVOM+Laser

p = 0.952

p = 0.387

p = 0.075

PPS

IVOM

5.00 ± 6.88 (p = 0.242)

0.25 ± 5.12 (p = 0.928)

5.25 ± 2.06 (p = 0.015)

IVOM+Laser

4.00 ± 7.29 (p = 0.165)

5.50 ± 5.21 (p = 0.020)

9.50 ± 5.26 (p = 0.001)

IVOM vs. IVOM+Laser

p = 0.824

p = 0.129

p = 0.158

  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); BCVA best corrected visual acuity;
  2. Comparisons between groups were done using Student’s t-test for dependent samples. BCVA changes are expressed in ETDRS charts for better statistical analysis
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BMC Ophthalmology

ISSN: 1471-2415

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