Design and analysis of wearable pupillometer for autonomic neuropathy of diabetic patients

Mei-Lan Ko; Yin-Yuan Chen; Yuan Ouyang; Ting-Wei Huang; Bi-Shiou Tsuen; Wei-De Jeng; Jin-Chern Chiou; Mang Ou-Yang

doi:10.1364/AO.53.000H27

Applied Optics
Vol. 53,
Issue 29,
pp. H27-H34
(2014)
•https://doi.org/10.1364/AO.53.000H27

Design and analysis of wearable pupillometer for autonomic neuropathy of diabetic patients

Mei-Lan Ko, Yin-Yuan Chen, Yuan Ouyang, Ting-Wei Huang, Bi-Shiou Tsuen, Wei-De Jeng, Jin-Chern Chiou, and Mang Ou-Yang

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Mei-Lan Ko, Yin-Yuan Chen, Yuan Ouyang, Ting-Wei Huang, Bi-Shiou Tsuen, Wei-De Jeng, Jin-Chern Chiou, and Mang Ou-Yang, "Design and analysis of wearable pupillometer for autonomic neuropathy of diabetic patients," Appl. Opt. 53, H27-H34 (2014)

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Abstract

Diabetes is a familiar disease in modern society. In the early stage of diabetes, symptoms are unobvious, but they usually induce diabetic autonomic neuropathy or, worse, cardiovascular autonomic neuropathy. Pupillometers are effective instruments for observing human pupils. This article presents a novel wearable pupillometer design, without external light artifacts, and an embedded algorithm with blinking elimination, which investigates autonomic neuropathy through recording pupil dynamics triggered by an external sensitive invisible light source. The pupillometer is experimented on 36 healthy subjects and 10 diabetic patients under four different colors (white, red, green, and blue) as well as two different light intensities: 50 and 500 mcd. Ten parameters derived from pupil diameter, pupil response time, and pupil response speed will be evaluated for the healthy subjects and diabetic patients. The results show that three in four parameters related to pupil diameters, one in four related to light intensities, and one in two related to pupil response speed could have significant differences ( $p < 0.05$ ) between healthy subjects and diabetic patients. These parameters obtain over 85% sensitivity, 83% specificity, and 88% accuracy. The pupillometer is proven reliable, effective, portable, and inexpensive for diagnosing diabetes in an early stage.

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	Wavelength
	900 nm	400–872 nm	932–1300 nm
Reflectance	50%	$> 90 %$	$< 10 %$
Transmittance	50%	$< 10 %$	$> 90 %$

	LED Color
	White	Red	Green	Blue
Wavelength	—	640 nm ( $\pm 3 nm$ )	534 nm ( $\pm 3 nm$ )	470 nm ( $\pm 3 nm$ )
Intensity 1	50 mcd	50 mcd	50 mcd	50 mcd
Intensity 2	500 mcd	500 mcd	500 mcd	500 mcd
Stimulating time	10 ms	10 ms	10 ms	10 ms
Operating temperature	$- 25 - 85 ° C$	$- 25 - 80 ° C$	$- 25 - 80 ° C$	$- 25 - 80 ° C$
Forward current	20 mA	20 mA	20 mA	20 mA

	Healthy Subjects ( $N = 36$ )								Diabetic Patients ( $N = 10$ )
	50 mcd				500 mcd				50 mcd				500 mcd
	Mean (Standard Deviation)				Mean (Standard Deviation)				Mean (Standard Deviation)				Mean (Standard Deviation)
	W	R	G	B	W	R	G	B	W	R	G	B	W	R	G	B
$λ$ (nm)		640	534	470		640	534	470		640	534	470		640	534	470
1. RPD	0.58 (0.05)	0.58 (0.05)	0.57 (0.05)	0.57 (0.05)	0.58 (0.05)	0.57 (0.05)	0.57 (0.05)	0.57 (0.05)	0.51 (0.07)	0.49 (0.08)	0.50 (0.08)	0.49 (0.07)	0.52 (0.07)	0.51 (0.07)	0.51 (0.07)	0.51 (0.07)
2. MPD	0.47 (0.06)	0.46 (0.05)	0.45 (0.05)	0.44 (0.05)	0.46 (0.06)	0.45 (0.05)	0.44 (0.05)	0.43 (0.05)	0.42 (0.07)	0.41 (0.08)	0.37 (0.07)	0.35 (0.06)	0.42 (0.06)	0.39 (0.05)	0.38 (0.06)	0.36 (0.06)
3. RTD	0.55 (0.05)	0.55 (0.05)	0.54 (0.05)	0.54 (0.05)	0.55 (0.05)	0.54 (0.05)	0.54 (0.05)	0.53 (0.05)	0.49 (0.07)	0.47 (0.07)	0.47 (0.08)	0.46 (0.07)	0.49 (0.07)	0.48 (0.07)	0.48 (0.07)	0.47 (0.06)
4. RFA	0.11 (0.03)	0.11 (0.02)	0.12 (0.02)	0.13 (0.02)	0.12 (0.02)	0.12 (0.03)	0.13 (0.03)	0.13 (0.03)	0.09 (0.02)	0.09 (0.02)	0.16 (0.03)	0.13 (0.02)	0.12 (0.03)	0.12 (0.02)	0.13 (0.03)	0.15 (0.02)
5. LTC	0.16 (0.07)	0.16 (0.05)	0.17 (0.07)	0.17 (0.07)	0.19 (0.07)	0.19 (0.07)	0.17 (0.09)	0.18 (0.09)	0.25 (0.07)	0.25 (0.06)	0.23 (0.04)	0.20 (0.05)	0.22 (0.03)	0.19 (0.07)	0.20 (0.05)	0.20 (0.07)
6. DCM	0.75 (0.06)	0.73 (0.05)	0.77 (0.05)	0.80 (0.05)	0.79 (0.06)	0.83 (0.05)	0.80 (0.05)	0.82 (0.05)	0.80 (0.10)	0.77 (0.12)	0.83 (0.06)	0.84 (0.07)	0.81 (0.09)	0.82 (0.06)	0.82 (0.07)	0.89 (0.06)
7. DRP	1.88 (0.77)	1.83 (0.88)	2.36 (1.54)	2.21 (1.40)	2.30 (1.11)	2.20 (0.98)	2.52 (1.14)	2.89 (1.30)	2.80 (0.96)	2.65 (0.93)	1.76 (0.06)	2.32 (1.02)	2.17 (0.07)	2.19 (1.22)	2.80 (1.30)	3.18 (1.51)
8. DRR	2.77 (1.17)	2.56 (0.95)	2.93 (1.18)	3.01 (1.39)	3.08 (1.17)	3.03 (0.99)	3.32 (1.20)	3.72 (1.36)	2.94 (1.22)	2.76 (1.18)	1.59 (0.63)	3.16 (1.14)	2.98 (0.83)	3.01 (1.35)	3.62 (1.30)	4.07 (1.53)
9. MCV	109.5 (44.6)	111.1 (43.2)	113.9 (40.0)	127.7 (40.1)	113.0 (41.9)	106.8 (32.3)	114.5 (31.7)	122.4 (41.5)	101.5 (25.3)	89.4 (26.1)	99.4 (33.2)	105.9 (19.7)	102.4 (16.6)	102.7 (20.7)	114.3 (22.5)	114.4 (22.9)
10.MRV	48.0 (12.9)	45.7 (12.4)	47.9 (14.1)	52.2 (12.3)	48.5 (9.8)	47.3 (12.7)	47.3 (13.4)	48.4 (14.2)	33.2 (5.1)	30.6 (11.2)	38.9 (11.0)	42.1 (13.5)	43.6 (7.2)	41.9 (6.9)	37.6 (14.3)	45.7 (9.9)

	50 mcd				500 mcd
	W	R	G	B	W	R	G	B
1. RPD	0.003	0.005	0.003	0.001	0.014	0.018	0.020	0.014
2. MPD	0.079	0.060	0.027	0.002	0.020	0.021	0.008	0.003
3. RTD	0.005	0.009	0.005	0.001	0.017	0.010	0.019	0.015
4. RFA	0.222	0.115	0.317	0.899	0.656	0.566	0.611	0.300
5. LTC	0.003	0.001	0.033	0.668	0.404	0.821	0.614	0.623
6. DCM	0.597	0.794	0.395	0.625	0.569	0.425	0.806	0.286
7. DRP	0.958	0.888	0.438	0.574	0.866	0.658	0.686	0.548
8. DRR	0.905	0.857	0.658	0.526	0.818	0.522	0.686	0.548
9. MCV	0.878	0.231	0.580	0.194	0.590	0.702	0.566	0.508
10. MRV	0.002	0.011	0.115	0.128	0.177	0.074	0.107	0.612

	Average Magnitude (Diabetes, Health)	Average SD (Diabetes, Health)	Difference of Magnitude Between Diabetes and Health	Difference of SD Between Diabetes and Health	$p$ value	Sensitivity	Specificity	Accuracy
1. RPD	(0.57, 0.51)	(0.005, 0.010)	$- 12.0 %$	45.3%	$< 0.01$	100.0%	92.2%	99.9%
2. MPD	(0.45, 0.39)	(0.013, 0.027)	$- 14.0 %$	22.1%	$< 0.01$	92.2%	95.8%	94.0%
3. RTD	(0.54, 0.48)	(0.007, 0.010)	$- 12.2 %$	40.4%	$< 0.01$	99.9%	99.9%	99.9%
4. RFA	(0.12, 0.12)	(0.008, 0.025)	1.5%	$- 4.9 %$	0.57	42.0%	55.2%	49.2%
5. LTC	(0.17, 0.22)	(0.011, 0.023)	26.2%	$- 22.7 %$	$< 0.01$	94.9%	83.1%	88.9%
6. DCM	(0.78, 0.82)	(0.034, 0.034)	4.7%	54.7%	0.33	70.4%	67.8%	69.1%
7. DRP	(2.27, 2.48)	(0.340, 0.454)	11.0%	$- 12.7 %$	0.65	76.8%	44.3%	61.0%
8. DRR	(3.05, 3.02)	(0.350, 0.717)	$- 1.5 %$	$- 0.5 %$	0.55	27.6%	90.9%	60.8%
9. MCV	(114.9, 113.8)	(6.908, 8.125)	$- 9.6 %$	$- 39.9 %$	0.13	72.9%	79.8%	76.4%
10. MRV	(48.2, 39.2)	(1.848, 5.190)	18.7%	$- 19.1 %$	$< 0.01$	85.9%	96.3%	91.2%

	Pupillometer Type
Capability	This Article	General [11,19]
Volume	$2.9 cm \times 5.2 cm \times 4.8 cm$	$14.5 cm \times 14.5 cm \times 17 cm$
Weight	78 g	$> 200 g$
Movable axis	2 Dimensions	None
Number of detectors	2	1
Number of stimulations	4 (WRGB)	1
CCD resolution	76 fps	30 fps
LTC sensitivity	94.9%	86.2%
LTC specificity	83.1%	78.9%

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