Comparison of Two Different Pupillometer

Sponsor
He Eye Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05717244
Collaborator
(none)
100
1
7
14.2

Study Details

Study Description

Brief Summary

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Device: 2WIN
  • Device: OPD

Detailed 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.

The purpose of this study is to assess the consistency of pupil diameter measurements between the two machines.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Two Pupillometer for Determining Pupil Diameter in Healthy Participants
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Pupil size [1 day]

    Photopic and mesopic pupil size will be measured using 2WIN photoscreening with OPD Scan III.

Secondary Outcome Measures

  1. Refractive Accuracy [1 day]

    Refractive measurements using 2WIN photoscreening with Nidek ARK-1 Autorefractor.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 18 years old

  • signed informed consent

  • willing to participate in the study

Exclusion Criteria:
  • abnormalities of the pupil (e.g., synechia, ectopia)

  • corneal scars

  • irregular astigmatism

  • strabismus

  • acute or chronic uveitis

  • any kind of previous eye surgery

  • medication that could have an influence on pupil reaction or size

Contacts and Locations

Locations

Site City State Country Postal Code
1 He Eye Hospital Shenyang Liaoning China 110001

Sponsors and Collaborators

  • He Eye Hospital

Investigators

  • Study Chair: Emmanuel E Pazo, MD, PhD, He Eye Hospital, Shenyang, China

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
He Eye Hospital
ClinicalTrials.gov Identifier:
NCT05717244
Other Study ID Numbers:
  • 2WIN2023
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 14, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by He Eye Hospital

Study Results

No Results Posted as of Feb 14, 2023