Performance of a Translucent Activator for LipiFlow Vectored Thermal Pulse (VTP) Treatment of Meibomian Gland Dysfunction

Figures & data

Table 1 Demographic and Baseline Characteristics

Category	Classification	All Subjects (n=44)
Sex	Male	13 (29.5%)
	Female	31 (70.5%)
Race	American Indian/Alaska Native	0 (0%)
	Asian (Includes Indian)	2 (4.5%)
	Black or African American	0 (0%)
	Caucasian	42 (95.5%)
	Other (includes Hispanic and Mixed)	0 (0%)
Age (Years)	Mean ± SD	67.0 ± 7.9
	Min - Max	45–85

Table 2 Questionnaire Items - LipiFlow Treatment with Activator CLEAR

Successful Completion of Treatment	n	%
Were the Activators CLEAR able to complete a successful treatment?
Yes	88	100.0%
No	0	0%
Feedback on the Activators CLEAR
1. Due to the translucent components of the Activator CLEAR, do you agree it is easy to confirm the Activator is in the right position in the patient’s eye?
4-Agree	4	4.5%
5-Strongly agree	84	95.5%
2. Due to the translucent components of the Activator CLEAR, do you agree you can efficiently position the Activator in the patient’s eye?
4-Agree	4	4.5%
5-Strongly agree	84	95.5%
3. Due to the translucent components of the Activator CLEAR, do you agree you have confidence in the position of the Activator in the patient’s eye during the treatment?
4-Agree	2	2.3%
5-Strongly agree	86	97.7%
4. Due to the translucent components of the Activator CLEAR, do you agree you can easily assess the position of the Activator in the patient’s eye during the treatment?
4-Agree	2	2.3%
5-Strongly agree	86	97.7%

Table 3 Summary of LipiFlow Treatment with Activator CLEAR Questionnaire Rating Scores

	N	Mean	Median	Std	Min	Max
How would you rate the ease of disinfecting the Cable?	88	5.0	5.0	0.0	5.0	5.0
How would you rate the ease of getting a full connection between the Activators CLEAR and the Cables?	88	5.0	5.0	0.2	4.0	5.0
How would you rate the task of connecting the Cables to the Activators CLEAR while maintaining lid warmer sterility?^a	86	4.9	5.0	0.3	4.0	5.0
How would you rate the ease of conducting the Activators CLEAR self-test?	88	5.0	5.0	0.0	5.0	5.0
How would you rate the ease of handling the Activators CLEAR for inspection?	88	5.0	5.0	0.0	5.0	5.0
How would you rate the ease of placing the Activators CLEAR in the subject’s eyes?	88	4.9	5.0	0.4	3.0	5.0
How would you rate the ease of determining the correct orientation?	88	5.0	5.0	0.0	5.0	5.0
How would you rate the ease of completing a treatment with Activators CLEAR?	88	4.9	5.0	0.4	2.0	5.0
How would you rate the task of removing the Activators CLEAR from the subject’s eyes?	88	4.9	5.0	0.4	3.0	5.0
How would you rate the task of disconnecting the Activators CLEAR from the Cable?	88	5.0	5.0	0.0	5.0	5.0
How would you rate how well the Activators CLEAR bladder fits on the eyelids?	88	5.0	5.0	0.1	4.0	5.0
How well was the Activators CLEAR secured into the proper and stable position in the subject’s eyes?	88	4.9	5.0	0.4	3.0	5.0
How would you rate the task of securing the Activators CLEAR with tape?	88	4.9	5.0	0.3	4.0	5.0
How would you rate how the Activators CLEAR remained in position under the eyelids during treatment?	88	5.0	5.0	0.1	4.0	5.0
Due to the translucent components of the Activator CLEAR, do you agree it is easy to confirm the Activator is in the right position in the patient’s eye?	88	5.0	5.0	0.2	4.0	5.0
Due to the translucent components of the Activator CLEAR, do you agree you can efficiently position the Activator in the patient’s eye?	88	5.0	5.0	0.2	4.0	5.0
Due to the translucent components of the Activator CLEAR, do you agree you have confidence in the position of the Activator in the patient’s eye during the treatment?	88	5.0	5.0	0.1	4.0	5.0
Due to the translucent components of the Activator CLEAR, do you agree you can easily assess the position of the Activator in the patient’s eye during the treatment?	88	5.0	5.0	0.1	4.0	5.0

Note: ^aNot answered by investigator for one subject.

Table 4 Ocular Surface Staining – Cornea (N=88 Eyes); Staining Scale 0–15

Label	Mean	Std Dev
Pre-treatment	3.1	1.9
Post-Treatment	3.9	2.3
Difference	0.9	1.6

Table 5 Ocular Surface Staining – Conjunctiva (N=88 Eyes); Staining Scale 0–18

Label	Mean	Std Dev
Pre-treatment	3.4	2.3
Post-Treatment	4.3	2.9
Difference	0.9	2.1