8 hrs Safety Evaluation Of A Multi-Pressure Dial In Eyes With Glaucoma: Prospective, Open-Label, Randomized Study

Figures & data

Figure 1 Multi-pressure dial, which includes the goggles connected to a handheld pressure-modulating pump. This device was worn for the duration of the 8-hr study period in this study.

Figure 2 This graph demonstrates the mean IOP values at each time point and were collected via Goldmann applanation tonometry (GAT). These measurements were taken without the MPD. The error bars represent standard deviation (SD).

Table 1 Baseline Characteristics

Parameter
Age, years (Mean, SD)	65.2 ± 12.5
Gender (M/F)	5 M/5 F
Ethnicity	100% White
BCVA (mean ± SD)
Study eye	0.00 ± 0.15
Fellow eye	−0.01 ± 0.10
IOP, mean ± SD, range
Study eye (mmHg)	15.75 ± 4.4, 11–24
Fellow eye (mmHg)	15.40 ± 4.4, 11–23
Visual Field Parameters
Study eye
VFI (%), mean ± SD	0.9 ± 0.2
Mean deviation (dB), mean ± SD	−3.4 ± 7.0
Pattern standard deviation (dB), mean ± SD	3.6 ± 3.2
Fellow eye
VFI (%), mean ± SD	0.9 ± 0.2
Mean deviation (dB), mean ± SD	−2.6 ± 6.1
Pattern standard deviation (dB), mean ± SD	2.5 ± 3.9
Cup-disc ratio, mean ± SD
Study eye	0.6 ± 0.2
Fellow eye	0.6 ± 0.2

Abbreviations: BCVA, best-corrected visual acuity; VFI, visual field index; SD, standard deviation; dB, decibels.

Table 2 This Table Demonstrates The Results From The Hourly Questionnaire Administered During The 8-hr Study Period. For This Assessment, The Scale Was 1=Best, 10=Worst

Hourly Questionnaire – Administered Hourly During 8-hr Study Period
Question	Response (Mean, SD) Scale: 1=Best, 10=Worst
	Hour 1	Hour 2	Hour 3	Hour 4	Hour 5	Hour 6	Hour 7	Hour 8	Total
How are you tolerating the multi-pressure dial?	2.1±1.9	2.3±1.8	2.3±2.8	1.4±0.9	1.6±0.9	1.6±0.9	1.5±0.9	1.6±1.1	1.8±0.4
How Comfortable/uncomfortable is the MPD?	2.1±1.9	2.1±2.1	2.2±2.8	1.7±0.9	1.8±0.8	1.8±1.2	1.5±0.9	1.7±1.1	1.9±0.3
How acceptable was the MPD negative pressure?	1.3±0.7	1.9±2.2	2.1±2.8	1.2±0.4	1.3±0.5	1.4±1.0	1.3±0.7	1.3±0.7	1.5±0.3
What is the likelihood of you wearing the device almost every night?	2.2±1.7	2.0±1.9	2.2±2.8	1.3±0.7	1.4±1.0	1.1±0.3	1.3±0.7	1.1±0.3	1.6±0.5
What is your attitude towards MPD as a glaucoma therapy?	2.6±1.7	2.2±1.8	2.3±2.9	1.6±1.0	1.7±0.9	1.3±0.7	1.3±0.5	1.2±0.7	1.8±0.5
How do you feel about continuing or stopping the therapy?	1.1±0.3	1.4±0.4	1.9±2.9	1.0±0.0	1.0±0.0	1.1±0.3	1.1±0.4	1.1±0.3	1.2±0.3

Table 3 This Table Demonstrates The Results From The Subjective Questionnaire That Was Administered After The 8 hr Study To Primarily Evaluate Comfort On Day 0

Initial Use Questionnaire
Question	Response (Mean, SD)
Comfort of the goggles, scale of 1–10 (1=not comfortable, 10 = comfortable)	2.8 ± 2.8
Comfort of the goggles strap, scale of 1–10 (1=not comfortable, 10 = comfortable)	1.3 ± 0.6
Comfort of the tubing, scale of 1–10 (1=not comfortable, 10 = comfortable)	1.7 ± 1.3

Abbreviation: SD, standard deviation.