Comparison of Two Different Pupillometer

Measurement of Pupil Diameter Clinical Trial

Official title:

Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717244
• Other study ID #: 2WIN2023
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2023
• Source: He Eye Hospital
• Contact: Liangzhe Li, M.D
• Phone: +8615504011747
• Email: 474860244[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pupil diameter is parameter of great interest in understanding brain systems and modern refractive surgery. Pupillometry, the measurement of variations in pupil dilation, has offered encouraging evidence for the involvement of disturbed reactivity in depression risk, according to studies. Traditional vision screening methods in children can be difficult due to poor cooperation and labour-intensive procedure, and therefore, a handheld photorefractometer offers reduced assessment time in detecting refractive errors. 2WIN uses infrared light, the patient is not aware of the several, rotating photoscreen images being exposed to afford multiaxial estimation of spherical and astigmatic refractive error.The purpose of this prospective study was to compare 2WIN and OPD Scan III pupillometers.

Description:

Pupil diameter is a parameter of great interest in understanding brain systems and modern refractive surgery. Pupillometry, the measurement of variations in pupil dilation, has offered encouraging evidence for the involvement of disturbed reactivity in depression risk, according to studies. According to research, the pupil dilates in reaction to stimuli requiring a larger cognitive load or a greater emotional intensity. Importantly, studies have related pupil size variations to brain activity in regions associated with emotion regulation, including the dorsolateral prefrontal cortex (DPFC) and the agenesis of the corpus callosum (ACC) . Thus, pupillometry is proposed as a viable peripheral gauge for a variety of brain systems involved in the processing of emotional information.

Some of the postoperative complaints of patients having refractive corneal or lens surgery are related to visual quality and are associated with large pupils since optical aberrations become more dominant when the pupil dilates . If the pupil size exceeds the optical zone size, a marked increase in higher-order aberrations could be observed. Patients might complain about poor contrast sensitivity, increased glare disability, or halos. Precise measurement of pupil diameter has therefore become an essential step in the preoperative evaluation of patients suitable for refractive surgery and is an important inclusion or exclusion criterion.

This study aimed to assess the agreement and reproducibility of scotopic pupil size measurements using 2WIN-S compared with OPD-Scan III in Chinese adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years old

• signed informed consent

• willing to participate in the study

Exclusion Criteria:

Exclusion criteria were ocular pathology known to interfere with pupillometer outcome and pupil abnormalities (eg: glaucoma, iritis, cataract, corneal scarring, any history of ocular surgery, and history of trauma.)

Related Conditions & MeSH terms

• Measurement of Pupil Diameter

Intervention

Device:
• 2WIN-S
Determining pupil diameter by 2WIN-S
• OPD
Determining pupil diameter by OPD

Locations

Country	Name	City	State
China	He Eye Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

Critchley HD, Tang J, Glaser D, Butterworth B, Dolan RJ. Anterior cingulate activity during error and autonomic response. Neuroimage. 2005 Oct 1;27(4):885-95. doi: 10.1016/j.neuroimage.2005.05.047. — View Citation

Fardell J. Poverty and infant deaths. Nurs Times. 1989 Jan 11-17;85(2):18. No abstract available. — View Citation

Jones NP, Siegle GJ, Mandell D. Motivational and emotional influences on cognitive control in depression: A pupillometry study. Cogn Affect Behav Neurosci. 2015 Jun;15(2):263-75. doi: 10.3758/s13415-014-0323-6. — View Citation

Martinez CE, Applegate RA, Klyce SD, McDonald MB, Medina JP, Howland HC. Effect of pupillary dilation on corneal optical aberrations after photorefractive keratectomy. Arch Ophthalmol. 1998 Aug;116(8):1053-62. doi: 10.1001/archopht.116.8.1053. — View Citation

Rosen ES, Gore CL, Taylor D, Chitkara D, Howes F, Kowalewski E. Use of a digital infrared pupillometer to assess patient suitability for refractive surgery. J Cataract Refract Surg. 2002 Aug;28(8):1433-8. doi: 10.1016/s0886-3350(01)01350-5. — View Citation

Siegle GJ, Granholm E, Ingram RE, Matt GE. Pupillary and reaction time measures of sustained processing of negative information in depression. Biol Psychiatry. 2001 Apr 1;49(7):624-36. doi: 10.1016/s0006-3223(00)01024-6. — View Citation

Siegle GJ, Steinhauer SR, Friedman ES, Thompson WS, Thase ME. Remission prognosis for cognitive therapy for recurrent depression using the pupil: utility and neural correlates. Biol Psychiatry. 2011 Apr 15;69(8):726-33. doi: 10.1016/j.biopsych.2010.12.041. — View Citation

Siegle GJ, Steinhauer SR, Stenger VA, Konecky R, Carter CS. Use of concurrent pupil dilation assessment to inform interpretation and analysis of fMRI data. Neuroimage. 2003 Sep;20(1):114-24. doi: 10.1016/s1053-8119(03)00298-2. — View Citation

Urry HL, van Reekum CM, Johnstone T, Kalin NH, Thurow ME, Schaefer HS, Jackson CA, Frye CJ, Greischar LL, Alexander AL, Davidson RJ. Amygdala and ventromedial prefrontal cortex are inversely coupled during regulation of negative affect and predict the diurnal pattern of cortisol secretion among older adults. J Neurosci. 2006 Apr 19;26(16):4415-25. doi: 10.1523/JNEUROSCI.3215-05.2006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scotopic pupil size	Scotopic pupil size will be measured using 2WIN-S with OPD-Scan III.	1 day
Secondary	refraction	Refraction will be measured using 2WIN-S with ARK-1.	1 day