Clinical trial NCT04595227: Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device
Official title: Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device Via Iris Recognition Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma
Primary Open-Angle Glaucoma, Unspecified Eye
Primary Open Angle Glaucoma of Both Eyes
Suspect Glaucoma
Ocular Hypertension
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants are recruited from patients visiting at the Ophthalmologic Center of Peking University Third Hospital and from the general population through advertisements.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum Constriction Velocity in One Eye in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Maximum Dilation Velocity in One Eye in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Pupil Constriction Amplitude(ratio) in One Eye in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Baseline Pupil Size in One Eye in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
measure: Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different Groups
timeFrame: The test of each participant will complete the all procedures within 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hosipital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Chun Zhang, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: