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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension; Primary Open Angle Glaucoma of Both Eyes; Primary Open-Angle Glaucoma, Unspecified Eye; Suspect Glaucoma
• Intervention / Treatment: Device: Computerized pupillary light reflex assessment device

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Chun Zhang, MD/PhD; Phone Number: +8618601031059; Email: zhangc1@yahoo.com
• Study Contact Backup: Name: Di Zhang, Bachelor; Phone Number: +8618813118298; Email: zhangdipku@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hosipital
      • Contact: Chun Zhang, MD/PhD; Phone Number: +8618601031059; Email: zhangc1@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Subjects; Healthy eyes had intraocular pressure of less than 22 mmHg with no history of increased intraocular pressure and normal standard automated perimetry (SAP) results.	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.
Suspect Glaucoma; Eyes with suspect glaucoma were defined as those with suspicious neuroretinal rim thinning or retinal nerve fiber layer (RNFL) defects on masked stereophotographic assessment, without repeatable abnormal SAP results. Eyes with suspect glaucoma also included those with intraocular pressure (IOP) > 21 mm Hg but with healthy-appearing optic discs and without repeatable abnormal SAP results	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.
Primary Open Angle Glaucoma, early stage; Eyes were classified as glaucomatous if they had repeatable (≥2 consecutive) abnormal SAP(Humphrey) test results or progressive glaucomatous changes on masked grading of stereophotographs, with or without abnormal SAP results. Abnormal SAP results were defined by a pattern standard deviation outside the 95% confidence limits or glaucoma hemifield test results outside the reference range.( -0.01dB≤MD≤-6.00dB)	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.
Primary Open Angle Glaucoma, moderate stage; Eyes were classified as glaucomatous if they had repeatable (≥2 consecutive) abnormal SAP(Humphrey) test results or progressive glaucomatous changes on masked grading of stereophotographs, with or without abnormal SAP results. Abnormal SAP results were defined by a pattern standard deviation outside the 95% confidence limits or glaucoma hemifield test results outside the reference range.( -6.01≤MD≤-12.00dB)	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.
Primary Open Angle Glaucoma, advanced stage; Eyes were classified as glaucomatous if they had repeatable (≥2 consecutive) abnormal SAP(Humphrey) test results or progressive glaucomatous changes on masked grading of stereophotographs, with or without abnormal SAP results. Abnormal SAP results were defined by a pattern standard deviation outside the 95% confidence limits or glaucoma hemifield test results outside the reference range.( -12.00≤MD≤-20.00dB)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Chun Zhang, MD/PHD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: IRB00006761-M2020269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No