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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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) |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized pupillary light reflex assessment device | 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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All participants are recruited from patients visiting at the Ophthalmologic Center of Peking University Third Hospital and from the general population through advertisements.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Zhang, MD/PhD | Contact | +8618601031059 | zhangc1@yahoo.com | |
| Di Zhang, Bachelor | Contact | +8618813118298 | zhangdipku@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun Zhang, MD/PhD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hosipital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| 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) |
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| 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. |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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