Thermal Pulsation with or without Dexamethasone Intracanalicular Insert for Meibomian Gland Dysfunction: A Prospective, Masked Trial

Figures & data

Table 1 Meibomian Gland Expressibility Scores and Other Endpoint Data by Treatment Group and Time Point

		Baseline		Week 1		Week 4		Week 12
		DEX	SHAM	DEX	SHAM	DEX	SHAM	DEX	SHAM
Meibomian gland expressibility score	Mean (SD)	13.3 (8.1)	16.3 (8.0)	26.8 (12.8)	26.4 (11.5)	29.3 (10.9)	29.7 (11.1)	29.8 (9.9)	27.3 (11.4)
	P value	0.182		0.866		0.895		0.399
	Mean (SD) CFB	–	–	13.5 (8.8)	10.1 (8.5)	16.1 (8.7)	13.4 (7.2)	16.5 (8.3)	10.9 (8.5)
	P value (within-group CFB)	–	–	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001	<0.0001
	P value (between-group CFB)	–		0.063		0.304		0.027
Tear osmolarity (mOsm/L)	Mean (SD)	305 (8.8)	309.1 (12.5)	305.1 (9.5)	313.5 (14.8)	309.1 (18.6)	310.5 (18.6)	307.6 (15.5)	310.8 (18.0)
	P value	0.122		0.011		0.709		0.897
	Mean (SD) CFB	–	–	0.1 (10.9)	4.5 (16.7)	4.1 (18.1)	1.5 (14.9)	2.9 (14.5)	1.7 (19.9)
	P value (within-group CFB)	–	–	0.983	0.258	0.342	0.673	0.410	0.726
	P value (between-group CFB)	–		0.331		0.603		0.828
Positive MMP-9	No. (%)	16 (84)	15 (79)	10 (53)	12 (63)	13 (68)	9 (47)	13 (68)	9 (47)
	P value	0.999		0.743		0.325		0.325
	No. (%) CFB	–	–	−6 (−46)	−3 (−16)	−3 (−16)	−6 (−32)	−3 (−16)	−6 (−46)
	P value (within-group CFB)	–	–	0.789	0.476	0.447	0.091	0.447	0.091
	P value (between-group CFB)	–		0.447		0.447		0.447
Ocular surface staining score	Mean (SD)	6.6 (6.3)	5.2 (4.7)	4.5 (5.9)	5.6 (4.7)	3.6 (4.6)	3.8 (4.3)	5.7 (5.9)	6.2 (6.5)
	P value	0.157				0.708		0.547
	Mean (SD) CFB	–	–	−2.2 (4.1)	0.4 (3.3)	−3.1 (3.3)	−1.4 (3.0)	−0.9 (3.7)	1.0 (4.2)
	P value (within-group CFB)	–	–	0.035	0.633	<0.001	0.061	0.280	0.312
	P value (between-group CFB)	–		0.071		0.028		0.095
TBUT	Mean (SD)	3.2 (2.2)	4.1 (3.4)	4.9 (4.6)	4.6 (3.3)	6.3 (5.8)	6.1 (5.5)	6.1 (4.8)	4.7 (3.4)
	P value	0.212		0.705		0.731		0.125
	Mean (SD) CFB	–	–	1.7 (3.3)	0.5 (2.2)	3.1 (4.4)	2.0 (3.5)	2.9 (3.33)	0.6 (3.3)
	P value (within-group CFB)	–	–	0.037	0.318	0.006	0.020	0.002	0.429
	P value (between-group CFB)	–		0.139		0.256		0.028

Abbreviations: MMP-9, matrix metalloproteinase-9; SD, standard deviation; TBUT, tear break-up time.

Table 2 Best-Corrected Visual Acuity (BCVA) and Intraocular Pressure (IOP) Safety Data by Treatment Group and Time Point

	Baseline			Week 1			Week 4			Week 12
	DEX	SHAM	P value	DEX	SHAM	P value	DEX	SHAM	P value	DEX	SHAM	P value
BCVA (ETDRS letters), mean (SD)	85.7 (4.1)	85.8 (4.4)	0.833	86.3 (5.1)	86.2 (3.8)	0.922	85.9 (5.2)	86.3 (4.0)	0.622	83.9 (14.0)	86.0 (3.6)
IOP, mean (SD)	13.4 (2.1)	13.6 (2.3)	0.448	13.6 (2.2)	13.2 (2.3)	0.439	14.1 (2.9)	13.3 (2.5)	0.109	14.1 (2.0)	13.9 (2.1)	0.716