Comparison of the iLUX and the LipiFlow for the Treatment of Meibomian Gland Dysfunction and Symptoms: A Randomized Clinical Trial

Figures & data

Figure 1 The iLUX MGD Treatment System. Reproduced with permission of Alcon.

Figure 2 CONSORT flow diagram presenting patient enrollment at each phase of the study for both the Lipiflow and iLUX treatment groups.

Table 1 Mean Meibomian Gland Scores (±SD) at Each Study Visit for Patients Treated with iLUX and LipiFlow. Change from Baseline at Weeks 2 and 4 are Also Shown Along with 95% Confidence Intervals

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	6.0 ± 3.7	5.9 ± 4.1	6.2 ± 4.9	6.4 ± 4.4
Week 2	21.7 ± 11.1	20.9 ± 11.0	21.5 ± 11.6	22.0 ± 12.0
Change	+15.7 ± 11.0	+15.2 ± 11.4	+15.4 ± 11.5	+15.5 ± 11.1
95% CI	+13.1, +18.3	+12.4, +17.9	+12.6, +18.2	+12.9, +18.2
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 4	23.2 ± 12.1	23.8 ± 11.4	24.3 ± 11.2	23.3 ± 11.9
Change	+17.3 ± 12.1	+18.0 ± 12.2	+18.1 ± 10.8	+16.9 ± 11.5
95% CI	+14.4, +20.2	+15.1, +21.0	+15.6, +20.7	+14.1, +19.6
P	<0.0001	<0.0001	<0.0001	<0.0001

Figure 3 Mean ± SD Meibomian Gland Scores in the right eyes of subjects in the iLUX and LipiFlow groups at baseline and 2 and 4 weeks after treatment.

Table 2 Mean Tear Break-Up Time (±SD) in Seconds at Each Study Visit for Patients Treated with iLUX and LipiFlow. Change from Baseline at Weeks 2 and 4 are Also Shown Along with 95% Confidence Intervals

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	3.9 ± 1.9	3.7 ± 1.8	3.9 ± 2.0	3.8 ± 2.0
Week 2	6.3 ± 3.1	6.2 ± 3.0	6.5 ± 3.4	6.2 ± 3.0
Change	+2.5 ± 2.8	+2.4 ± 2.8	+2.5 ± 3.5	+2.3 ± 3.0
95% CI	+1.8, +3.1	+1.8, +3.1	+1.7, +3.4	+1.5, +3.0
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 4	6.7 ± 3.7	6.5 ± 3.6	6.6 ± 3.2	6.5 ± 3.1
Change	+2.9 ± 3.7	+2.7 ± 3.6	+2.7 ± 3.3	+2.6 ± 3.2
95% CI	+2.0, +3.7	+1.9, +3.6	+1.9, +3.5	+1.9, +3.4
P	<0.0001	<0.0001	<0.0001	<0.0001

Figure 4 Mean ± SD tear break-up times in the right eyes of subjects in the iLUX and LipiFlow groups at baseline and 2 and 4 weeks after treatment.

Table 3 Mean Ocular Surface Disease Index Scores (±SD) at Each Study Visit for Patients Treated with iLUX and LipiFlow. Change from Baseline at Weeks 2 and 4 are Also Shown Along with 95% Confidence Intervals

	iLUX	LipiFlow
Baseline	50.7 ± 18.6	50.6 ± 18.7
Week 2	22.1 ± 18.6	22.0 ± 17.7
Change	–27.8 ± 19.6	–28.5 ± 20.8
95% CI	–32.4, –23.2	–33.4, –23.6
P	<0.0001	<0.0001
Week 4	19.5 ± 17.0	22.6 ± 19.8
Change	–31.0 ± 18.4	–28.0 ± 22.8
95% CI	–35.3, –26.7	–33.3, –22.7
P	<0.0001	<0.0001

Figure 5 Mean ± SD Ocular Surface Disease Index scores of subjects in the iLUX and LipiFlow groups at baseline and 2 and 4 weeks after treatment.

Table 4 Mean Pain Scores (±SD) at Each Study Visit for Patients Treated with iLUX and LipiFlow. Changes from Baseline at 1 Day and 2 and 4 Weeks are Also Shown Along with Their 95% Confidence Intervals. The Post-Treatment Ratings Refer to Pain During the Procedure and are Not Compared with Baseline Values

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	34.4 ± 28.6	34.0 ± 28.0	30.8 ± 26.4	32.6 ± 27.6
Post-treatment	25.2 ± 25.1	23.6 ± 23.7	10.2 ± 14.6	10.1 ± 13.8
Day 1	12.0 ± 15.7	13.0 ± 17.0	11.8 ± 17.8	11.5 ± 16.9
Change	–22.4 ± 27.9	–21.0 ± 26.6	–19.1 ± 24.8	–21.1 ± 25.4
95% CI	–29.0, –15.8	–27.3, –14.7	–25.0, –13.1	–27.2, –15.0
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 2	8.4 ± 14.3	7.5 ± 12.3	9.1 ± 14.7	10.3 ± 15.9
Change	–25.4 ± 29.4	–25.8 ± 27.0	–22.4 ± 23.6	–22.9 ± 24.5
95% CI	–32.5, –18.4	–32.2, –19.3	–28.1, –16.6	–28.8, –17.0
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 4	8.3 ± 15.0	9.3 ± 16.2	10.9 ± 15.7	11.4 ± 16.2
Change	–26.3 ± 26.8	–24.9 ± 27.9	–20.0 ± 24.7	–21.3 ± 24.5
95% CI	–32.7, –19.9	–31.5, –18.2	–25.9, –14.1	–27.1, –15.4
P	<0.0001	<0.0001	<0.0001	<0.0001

Table 5 Mean Discomfort Scores (±SD) at Each Study Visit for Patients Treated with iLUX and LipiFlow. Changes from Baseline at 1 Day and 2 and 4 Weeks are Also Shown Along with Their 95% Confidence Intervals. The Post-Treatment Ratings Refer to Discomfort During the Procedure and are Not Compared with Baseline Values

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	56.3 ± 22.3	55.9 ± 21.8	52.1 ± 23.6	52.6 ± 24.0
Post-Treatment	38.9 ± 24.7	36.7 ± 22.5	22.3 ± 21.2	23.7 ± 21.6
Day 1	23.5 ± 22.5	23.7 ± 22.4	24. 7 ± 24.2	24.4 ± 23.4
Change	–32.8 ± 25.0	–32.2 ± 24.4	–27.2 ± 28.1	–28.2 ± 29.6
95% CI	–38.8, –26.9	–37.9, –26.4	–34.0, –20.5	–35.2, –21.1
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 2	15.8 ± 17.1	16.4 ± 17.7	18.1 ± 18.8	21.0 ± 20.4
Change	–40.0 ± 25.8	–38.8 ± 25.1	–33.5 ± 23.8	–31.2 ± 25.3
95% CI	–46.2, –33.8	–44.8, –32.7	–39.3, –27.7	–37.4, –25.1
P	<0.0001	<0.0001	<0.0001	<0.0001
Week 4	12.7 ± 15.3	14.0 ± 17.4	17.9 ± 20.4	19.5 ± 20.7
Change	–43.5 ± 25.0	–41.7 ± 26.9	–34.0 ± 24.5	–33.1 ± 25.1
95% CI	–49.5, –37.6	–48.2, –35.3	–39.9, –28.1	–39.1, –27.1
P	<0.0001	<0.0001	<0.0001	<0.0001

Table 6 Mean Corneal Staining Scores (±SD) at Each Study Visit for Patients Treated with iLUX and LipiFlow. Post-Treatment Changes from Baseline Along with Changes After 1 Day and 2 and 4 Weeks are Also Shown, Along with Their 95% Confidence Intervals

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	2.1 ± 2.2	2.3 ± 2.2	2.0 ± 2.2	2.5 ± 2.6
Post-treatment	2.6 ± 2.5	2.9 ± 2.8	2.0 ± 2.2	2.5 ± 2.6
Change	+0.6 ± 1.7	+0.6 ± 1.7	+0.5 ± 1.6	+0.4 ± 1.5
95% CI	+0.18, +0.97	+0.18, +1.00	+0.07, +0.84	–0.00, +0.72
P	0.005	0.005	0.021	0.052
Day 1	1.2 ± 1.9	1.3 ± 2.2	1.1 ± 2.0	1.2 ± 2.0
Change	–0.9 ± 1.8	–1.0 ± 2.0	–0.9 ± 1.5	–1.2 ± 1.9
95% CI	–1.29, –0.43	–1.46, –0.49	–1.26, –0.57	–1.68, –0.77
P	0.0001	0.0002	<0.0001	<0.0001
Week 2	1.0 ± 2.1	1.1 ± 2.1	1.0 ± 1.6	1.1 ± 1.5
Change	–1.0 ± 1.7	–1.1 ± 1.6	–1.0 ± 1.9	–1.4 ± 2.2
95% CI	–1.38, –0.56	–1.50, –0.71	–1.47, –0.53	–1.97, –0.91
P	<0.0001	<0.0001	0.0001	<0.0001
Week 4	1.5 ± 2.4	1.4 ± 2.2	0.9 ± 1.6	1.2 ± 1.6
Change	–0.6 ± 2.0	–0.9 ± 1.8	–1.1 ± 2.1	–1.3 ± 2.3
95% CI	–1.04, –0.07	–1.28, –0.43	–1.59, –0.61	–1.84, –0.73
P	0.025	0.0002	<0.0001	<0.0001

Table 7 Mean Visual Acuity (±SD) in logMAR at Each Study Visit for Patients Treated with iLUX and LipiFlow. Post-Treatment Changes from Baseline Along with Changes After 1 Day and 2 and 4 Weeks are Also Shown, Along with Their 95% Confidence Intervals

	iLUX		LipiFlow
	OD	OS	OD	OS
Baseline	–0.01 ± 0.12	–0.03 ± 0.10	+0.01 ± 0.16	+0.01 ± 0.13
Post-treatment	+0.01 ± 0.13	+0.02 ± 0.12	+0.03 ± 0.19	+0.02 ± 0.15
Change	+0.02 ± 0.08	+0.05 ± 0.11	+0.02 ± 0.11	+0.02 ± 0.07
95% CI	–0.00, +0.04	+0.02, +0.07	–0.00, +0.05	–0.00, +0.03
P	0.058	0.0005	0.074	0.062
Day 1	–0.02 ± 0.10	–0.03 ± 0.10	+0.01 ± 0.16	0.00 ± 0.13
Change	–0.01 ± 0.07	0.00 ± 0.07	0.00 ± 0.08	0.00 ± 0.07
95% CI	–0.03, +0.01	–0.02, +0.02	–0.02, +0.02	–0.02, +0.01
P	0.19	0.86	0.67	0.73
Week 2	–0.04 ± 0.10	–0.04 ± 0.10	–0.02 ± 0.15	–0.03 ± 0.12
Change	–0.03 ± 0.08	–0.01 ± 0.08	–0.02 ± 0.07	–0.03 ± 0.06
95% CI	–0.05, –0.01	–0.03, +0.01	–0.04, –0.00	–0.05, –0.02
P	0.001	0.27	0.017	0.0002
Week 4	–0.04 ± 0.12	–0.05 ± 0.11	–0.03 ± 0.16	–0.02 ± 0.13
Change	–0.03 ± 0.07	–0.02 ± 0.06	–0.04 ± 0.07	–0.03 ± 0.08
95% CI	–0.05, –0.01	–0.03, –0.00	–0.06, –0.02	–0.05, –0.01
P	0.0007	0.017	0.0001	0.0047

Figure 6 Mean meibomian gland scores (MGS), tear break-up time (TBUT) and OSDI scores before and 4 weeks after treatment with the LipiFlow device in the present study and in six previous studies.

Note: The plots are presented to demonstrate baseline variations and reported changes with treatment; however, the relationship between baseline and 4 weeks for all measurement cannot be assumed to be linear.