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

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Primary Open-Angle Glaucoma, Unspecified Eye; Suspect Glaucoma; Primary Open Angle Glaucoma of Both Eyes

• Registration Number: NCT04595227
• Lead Sponsor: Peking University

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.

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-18
• Study First Posted: 2020-10-20
• Study Start: 2020-10-30
• Primary Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different Groups	The 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)
Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different Groups	The 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)
Baseline Pupil Size in One Eye in Different Groups	The test of each participant will complete the all procedures within 1 hour.	The baseline pupil size is measured before the stimulus on.
Maximum Constriction Velocity in One Eye in Different Groups	The 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 Groups	The 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 Groups	The test of each participant will complete the all procedures within 1 hour.	The pupil constriction amplitude(ratio) will be calculated by the software.
Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different Groups	The 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)
Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different Groups	The 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)

Trial Locations

Locations (1)

Peking University Third Hosipital; 🇨🇳 Beijing, Beijing, China