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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Computerized pupillary light reflex assessment device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Subjects<br>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<br>* 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.<br>|
| Suspect Glaucoma<br>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<br>* 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.<br>|
| Primary Open Angle Glaucoma, early stage<br>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<br>* 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.<br>|
| Primary Open Angle Glaucoma, moderate stage<br>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<br>* 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.<br>|
| Primary Open Angle Glaucoma, advanced stage<br>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<br>* 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.<br>|

What is the study measuring?
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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. |