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Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device

Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device Via Iris Recognition Techniques

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04595227
Enrollment
100
Registered
2020-10-20
Start date
2020-10-30
Completion date
2021-10-01
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open Angle Glaucoma, Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye, Suspect Glaucoma

Brief 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.

Detailed 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.

Interventions

DEVICEComputerized 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.

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum Constriction Velocity in One Eye in Different GroupsThe test of each participant will complete the all procedures within 1 hour.The maximum constriction velocity will be calculated by the software
Maximum Dilation Velocity in One Eye in Different GroupsThe test of each participant will complete the all procedures within 1 hour.The maximum dilation velocity will be calculated by the software.
Pupil Constriction Amplitude(ratio) in One Eye in Different GroupsThe test of each participant will complete the all procedures within 1 hour.The pupil constriction amplitude(ratio) will be calculated by the software.
Baseline Pupil Size in One Eye in Different GroupsThe test of each participant will complete the all procedures within 1 hour.The baseline pupil size is measured before the stimulus on.
Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different GroupsThe test of each participant will complete the all procedures within 1 hour.Asymmetry is calculated by a formula: RAPD score of BPZ= 10 \* log10 (baseline pupil size in right eye/baseline pupil size in left eye)
Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different GroupsThe test of each participant will complete the all procedures within 1 hour.Asymmetry is calculated by a formula: RAPD score of MCV= 10 \* log10 (maximum constriction velocity in right eye/maximum constriction velocity in left eye)
Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different GroupsThe test of each participant will complete the all procedures within 1 hour.Asymmetry is calculated by a formula: RAPD score of MDV = 10 \* log10 (maximum dilation velocity in right eye/maximum dilation velocity in left eye)
Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different GroupsThe test of each participant will complete the all procedures within 1 hour.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)

Countries

China

Contacts

Primary ContactChun Zhang, MD/PhD
zhangc1@yahoo.com+8618601031059
Backup ContactDi Zhang, Bachelor
zhangdipku@163.com+8618813118298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026