Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device
NCT ID: NCT04595227
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-10-30
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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
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)
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)
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* best-corrected visual acuity ≥0.5
* spherical refraction within ±6.0 diopters (D), and cylinder correction within 3.0 D
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Peking University
OTHER
Responsible Party
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Chun Zhang
professor
Principal Investigators
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Chun Zhang, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hosipital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00006761-M2020269
Identifier Type: -
Identifier Source: org_study_id
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