Primary Open Angle GlaucomaNCT04595227
Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device
An observational study of Primary Open Angle Glaucoma and Primary Open-Angle Glaucoma, Unspecified Eye, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Open Angle Glaucoma, Primary Open-Angle Glaucoma, Unspecified Eye, Primary Open Angle Glaucoma of Both Eyes
- What is being tested?
- Computerized pupillary light reflex assessment device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hosipital
Beijing, Beijing Municipality, 100191
Chun Zhang, MD/PhD, +8618601031059, zhangc1@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Open Angle Glaucoma, Primary Open-Angle Glaucoma, Unspecified Eye, Primary Open Angle Glaucoma of Both Eyes, Suspect Glaucoma, Ocular Hypertension
- Being tested
- Computerized pupillary light reflex assessment device
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized pupillary light reflex assessment deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Computerized pupillary light reflex assessment device | |
| 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 Receives: Device: Computerized pupillary light reflex assessment device | |
| 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) Receives: Device: Computerized pupillary light reflex assessment device | |
| 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) Receives: Device: Computerized pupillary light reflex assessment device | |
| 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) Receives: Device: Computerized pupillary light reflex assessment device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Constriction Velocity in One Eye in Different Groups
The maximum constriction velocity will be calculated by the software
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The test of each participant will complete the all procedures within 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start30 Oct 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Zhang, Peking University
- Investigators
- Chun Zhang, MD/PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595227
- Sponsor's protocol ID
- IRB00006761-M2020269
- Status last verified
- May 2021
- First submitted
- 10 Oct 2020
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device Via Iris Recognition Techniques
- ClinicalTrials.gov ID
- NCT04595227
- Acronym / sponsor ID
- IRB00006761-M2020269
- Conditions
- Primary Open Angle Glaucoma, Primary Open-Angle Glaucoma, Unspecified Eye, Primary Open Angle Glaucoma of Both Eyes, Suspect Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Subjects | – | Device: Computerized pupillary light reflex assessment deviceHealthy eyes had intraocular pressure of less than 22 mmHg with no history of increased intraocular pressure and normal standard automated perimetry (SAP) results. |
| Suspect Glaucoma | – | Device: Computerized pupillary light reflex assessment deviceEyes 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 |
| Primary Open Angle Glaucoma, early stage | – | Device: Computerized pupillary light reflex assessment deviceEyes 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) |
| Primary Open Angle Glaucoma, moderate stage | – | Device: Computerized pupillary light reflex assessment deviceEyes 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) |
| Primary Open Angle Glaucoma, advanced stage | – | Device: Computerized pupillary light reflex assessment deviceEyes 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized pupillary light reflex assessment deviceCPLRAD 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. | Device | Normal Subjects, Primary Open Angle Glaucoma, advanced stage, Primary Open Angle Glaucoma, early stage, Primary Open Angle Glaucoma, moderate stage, Suspect Glaucoma |
Primary outcome
Maximum Constriction Velocity in One Eye in Different Groups
Time frame: 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
Time frame: 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
Time frame: The test of each participant will complete the all procedures within 1 hour.
The pupil constriction amplitude(ratio) will be calculated by the software.
Baseline Pupil Size in One Eye in Different Groups
Time frame: The test of each participant will complete the all procedures within 1 hour.
The baseline pupil size is measured before the stimulus on.
Baseline Pupil Size(BPZ) Asymmetry between Two Eyes in Different Groups
Time frame: 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)
Maximum Constriction Velocity(MCV) Asymmetry between Two Eyes in Different Groups
Time frame: 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)
Maximum Dilation Velocity(MDV) Asymmetry between Two Eyes in Different Groups
Time frame: 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)
Pupil Constriction Amplitude(ratio) Asymmetry between Two Eyes in Different Groups
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Zhang, MD/PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma and Primary Open-Angle Glaucoma, Unspecified Eye, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun Zhang, MD/PhD (+8618601031059, zhangc1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Constriction Velocity in One Eye in Different Groups (time frame: The test of each participant will complete the all procedures within 1 hour.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.