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

Peking University

Status: Unknown

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

Treatments: Device: Computerized pupillary light reflex assessment device

Study type: Observational

Funder types: Other

Identifiers

NCT04595227

IRB00006761-M2020269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 5 patient groups

Normal Subjects

Description:

Healthy eyes had intraocular pressure of less than 22 mmHg with no history of increased intraocular pressure and normal standard automated perimetry (SAP) results.

Treatment:

Device: Computerized pupillary light reflex assessment device

Suspect Glaucoma

Description:

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

Treatment:

Device: Computerized pupillary light reflex assessment device

Primary Open Angle Glaucoma, early stage

Description:

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)

Treatment:

Device: Computerized pupillary light reflex assessment device

Primary Open Angle Glaucoma, moderate stage

Description:

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)

Treatment:

Device: Computerized pupillary light reflex assessment device

Primary Open Angle Glaucoma, advanced stage

Description:

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)

Treatment:

Device: Computerized pupillary light reflex assessment device