Table 2.

OCT CST and Retinal Volume^*

OCT Outcomes	Treatment Group
	PBM (n = 68)	Placebo (n = 66)	PBM vs. Placebo Adjusted Mean Difference or Odds Ratio (95% CI) †	PBM vs. Placebo Adjusted Risk Difference (95% CI) †
OCT CST at baseline, μm (Spectralis equivalent)
Mean (SD)	366 (42)	359 (32)
OCT CST at 4 mos, μm (Spectralis equivalent)
Mean (SD)	379 (69)	374 (66)
OCT CST change from baseline to 4 mos, ‡,§μm
Mean (SD)	13 (53)	15 (57)	−2 (−20, 16) P = 0.84
Center-involved DME at 4 mos
n (%)	61 (90%)	57 (86%)	1.30 (0.44, 3.83) P = 0.63	3% (−19%, 27%)
OCT retinal volume at baseline,|| mm3 (Stratus equivalent)
Mean (SD)	7.82 (0.86)	7.73 (0.69)
OCT retinal volume at 4 mos,|| mm3 (Stratus equivalent)
Mean (SD)	7.91 (1.01)	7.85 (0.90)
OCT retinal volume change from baseline to 4 mos, ‡,¶ mm3
Mean (SD)	0.12 (0.45)	0.10 (0.42)	0.01 (−0.14, 0.15) P = 0.93

Abbreviations: CI = confidence interval; CST = central subfield thickness; DME = diabetic macular edema; SD = standard deviation; PBM = photobiomodulation.

^*Only eyes that completed the 4-month visit were included in the calculation of descriptive statistics of OCT data. For eyes that received alternate DME treatment before 4 months (n = 3 [PBM]; n = 1 [placebo]), the last OCT measurements before alternative DME treatment were used in the place of the 4- month measurements. All analyses followed the intent-to-treat principle.

^†PBM vs. placebo mean differences, odds ratios and risk differences were adjusted for baseline values of the outcome and the randomization stratification factor of recent or planned intravitreous treatment in the nonstudy eye.

^‡Multiple imputation (m = 100) was used for the missing values of CST and retinal volume change, with imputation models that were stratified by treatment and included variables for treatment group, baseline values, and change from baseline at all monthly interim visits up to the primary outcome visit and the randomization stratification factor of recent or planned intravitreous treatment in the nonstudy eye. Multiple imputation was not performed for CI-DME, given the thresholds are gender and machine specific.

^§OCT CST change was truncated to the mean ± 3 SD (13 ± 3 × 58)

^||OCT retinal volume was missing for 4 PBM and 3 placebo eyes at baseline and 5 PBM and 4 placebo eyes at 4 months.

^¶OCT retinal volume change was truncated to the mean ± 3 SD (0.09 ± 3 × 0.42) and missing for 8 PBM and 5 placebo eyes.