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

NCT04595227 | Unknown

• 1 other identifier: IRB00006761-M2020269
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (5)

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

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

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

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

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

Interventions

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.

Normal Subjects; Primary Open Angle Glaucoma, advanced stage; Primary Open Angle Glaucoma, early stage; Primary Open Angle Glaucoma, moderate stage; Suspect Glaucoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Third Hosipital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Chun Zhang, MD/PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Zhang, MD/PhD

CONTACT

+8618601031059; zhangc1@yahoo.com

Di Zhang, Bachelor

CONTACT

+8618813118298; zhangdipku@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 20, 2020
• Study Start: October 30, 2020
• Primary Completion: April 30, 2021
• Study Completion: October 1, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)