Randomized controlled trial on the efficacy and safety of autologous serum eye drops in dry eye syndrome

Table 1 Baseline characteristics of the participants

Variable	ASEDs group (n = 116)	Artificial tears group (n = 116)	P value
Age (yr)	54.6 ± 12.4	55.2 ± 11.8	0.63
Sex (female/male)	72/44	69/47	0.72
Duration of DES (mo)	18.4 ± 9.6	19.2 ± 10.2	0.51
Type of DES (aqueous-deficient/evaporative/mixed)	36/28/52	34/30/52	0.91
OSDI score	41.8 ± 10.4	42.1 ± 10.6	0.79
TBUT (s)	3.2 ± 1.1	3.3 ± 1.2	0.46
Schirmer I test (mm/5min)	3.4 ± 1.6	3.5 ± 1.7	0.68
CFS score	6.7 ± 2.1	6.8 ± 2.2	0.75
CIC score	2.1 ± 0.6	2.2 ± 0.7	0.54

Data are presented as mean ± SD or number. ASEDs: Autologous serum eye drops; DES: Dry eye syndrome; OSDI: Ocular surface disease index; TBUT: Tear break-up time; CFS: Corneal fluorescein staining; CIC: Conjunctival impression cytology.

Table 2 Changes in ocular surface disease index score and other secondary outcomes from baseline to week 12

Variable	ASEDs group (n = 116)	Artificial tears group (n = 116)	P value
OSDI score	-26.4 ± 9.8 (-38%)	-16.1 ± 8.9 (-19%)	< 0.001
TBUT (s)	+2.4 ± 1.3 (+75%)	+0.6 ± 0.9 (+18%)	< 0.001
Schirmer I test (mm/5 min)	+4.6 ± 2.4 (+135%)	+1.5 ± 1.8 (+43%)	< 0.001
CFS score	-3.4 ± 1.8 (-51%)	-1.9 ± 1.6 (-28%)	< 0.001
CIC score	-1.2 ± 0.5 (-57%)	-0.5 ± 0.4 (-23%)	< 0.001

Data are presented as mean ± SD and percentage change in parentheses. ASEDs: Autologous serum eye drops; OSDI: Ocular surface disease index; TBUT: Tear break-up time; CFS: Corneal fluorescein staining; CIC: Conjunctival impression cytology.