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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04595227
Other study ID # IRB00006761-M2020269
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 30, 2020
Est. completion date October 1, 2021

Study information

Verified date May 2021
Source Peking University
Contact Chun Zhang, MD/PhD
Phone +8618601031059
Email zhangc1@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore an effective diagnostic tool of glaucoma through the dynamic analysis of computerized pupillary light reflex assessment device (CPLRAD) pupillography based on iris recognition techniques and investigate its feasibility in glaucoma screening.


Description:

Glaucoma is the leading cause of irreversible blindness worldwide, which is characterized by progressive loss of retinal ganglion cells (RGCs) and their optic nerve axons. Early diagnosis and treatment can effectively prevent the progression of the disease and avoid blindness. The damage of RGCs appears in the early stage of glaucoma, and the asymmetry of the eyes has also been observed clinically. CPLRAD may serve as an effective screening tool for glaucomatous optic neuropathy, since they can dynamically detect abnormal pupillary responses from a novel sequence of light stimuli and functionally-shaped stimuli. The current theoretical evidence of relative afferent pupillary defect/pupillary light reflex (RAPD/PLR) as a functional test for predicting nerve damage is insufficient, and pupil detection technology is not yet mature. Therefore, the investigators want to complete these tasks: 1) collect the clinical examination data and objectively measure the pupil dynamic parameters monocularly and/or binocularly as indicators from the retina and optic nerve in glaucoma patients 2) design RAPD/PLR detection technology and develop dynamic analysis system; 3) verify the feasibility of RAPD/PLR applied to early glaucoma screening through clinical trials. The pupil image dynamic analysis and iris recognition system will provide a simple, inexpensive and non-invasive screen tool, and is highly reliable and cost-effective.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 1, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - with open angles on gonioscopy - best-corrected visual acuity =0.5 - spherical refraction within ±6.0 diopters (D), and cylinder correction within 3.0 D Exclusion Criteria: - eyes with any evidence of physical abnormality of the iris or pupils on slit-lamp examination - eyes with a history of trauma or inflammation - undergone an intraocular surgery or laser within the previous 6 months /except uncomplicated cataract surgery - using systemic or topical medications that could affect pupil responses, including pilocarpine or atropine - presence of any media opacities that prevented good quality optical coherence tomography (OCT) or fundus images - presence of any retinal or neurological disease other than glaucoma abnormal ocular motility that prevents binocular fixation (eg, nystagmus, strabismus) - with severe system diseases or psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Computerized pupillary light reflex assessment device
CPLRAD may serve as an effective screening tool for glaucomatous optic neuropathy, since they can dynamically detect abnormal pupillary responses from a novel sequence of light stimuli and functionally-shaped stimuli. CPLRAD can collect the clinical examination data and objectively measure the pupil dynamic parameters monocularly and/or binocularly as indicators from the retina and optic nerve in glaucoma patients.

Locations

Country Name City State
China Peking University Third Hosipital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Constriction Velocity in One Eye in Different Groups The maximum constriction velocity will be calculated by the software The test of each participant will complete the all procedures within 1 hour.
Primary Maximum Dilation Velocity in One Eye in Different Groups The maximum dilation velocity will be calculated by the software. The test of each participant will complete the all procedures within 1 hour.
Primary Pupil Constriction Amplitude(ratio) in One Eye in Different Groups The pupil constriction amplitude(ratio) will be calculated by the software. The test of each participant will complete the all procedures within 1 hour.
Primary Baseline Pupil Size in One Eye in Different Groups The baseline pupil size is measured before the stimulus on. The test of each participant will complete the all procedures within 1 hour.
Primary Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different Groups Asymmetry is calculated by a formula:
RAPD score of BPZ= 10 * log10 (baseline pupil size in right eye/baseline pupil size in left eye)
The test of each participant will complete the all procedures within 1 hour.
Primary Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different Groups Asymmetry is calculated by a formula:
RAPD score of MCV= 10 * log10 (maximum constriction velocity in right eye/maximum constriction velocity in left eye)
The test of each participant will complete the all procedures within 1 hour.
Primary Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different Groups Asymmetry is calculated by a formula:
RAPD score of MDV = 10 * log10 (maximum dilation velocity in right eye/maximum dilation velocity in left eye)
The test of each participant will complete the all procedures within 1 hour.
Primary Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different Groups Amplitude(ratio) is calculated by: (DIAMETER resting-DIAMETER constricted) / DIAMETER resting
Asymmetry was calculated by a formula:
RAPD score of Amplitude = 10 * log10 (pupil constriction amplitude in right eye/pupil constriction amplitude in left eye)
The test of each participant will complete the all procedures within 1 hour.
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