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

May 5, 2021 updated by: Chun Zhang, Peking University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hosipital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
The test of each participant will complete the all procedures within 1 hour.
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.
The test of each participant will complete the all procedures within 1 hour.
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.
The test of each participant will complete the all procedures within 1 hour.
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.
The test of each participant will complete the all procedures within 1 hour.
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)
The test of each participant will complete the all procedures within 1 hour.
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)
The test of each participant will complete the all procedures within 1 hour.
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)
The test of each participant will complete the all procedures within 1 hour.
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)
The test of each participant will complete the all procedures within 1 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun Zhang, MD/PHD, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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