The Diagnostic Performance of BMO-MRW and RNFL Thickness and Their Combinational Index Using Artificial Neural Network

The Comparison of Bruch's Membrane Opening-minimum Rim Width and Retinal Nerve Fiber Layer Thickness and Their Combinational Index Using Artificial Neural Network

This study evaluates the relationship between BMO-MRW and RNFL thickness measured by OCT. SD-OCT exam will be performed to all patients in this study.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Tomography, Optical Coherence
• Intervention / Treatment: Diagnostic test: SD-OCT

Detailed Description

spectral domain optical coherence tomography, SD-OCT, (Heidelberg Engineering, Heidelberg, Germany) is a widely used commercial device in ophthalmology field. For a long time, retinal nerve fiber layer (RNFL) thickness was measured with OCT to detect and follow up glaucoma patients. Bruch's membrane opening - minimum rim width (BMO-MRW) is relatively new parameter which measures the minimum distance between Bruch's membrane opening to internal limiting membrane (ILM). BMO-MRW,a new parameter, is known to have better diagnostic performance than RNFL thickness and recently, many researches has been performed on this new parameter. SD-OCT can measure RNFL thickness and BMO-MRW at the same time. The test procedure is not different from RNFL thickness measurement but only software implemented in OCT device calculates BMO-MRW as well as RNFL thickness. The investigators are going to compare these two parameters and find out the relationship between two parameters.

• Study Type: Observational
• Enrollment (Actual): 402

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49214
    • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who visited Pusan National University Hospital glaucoma clinic.

Description

Inclusion Criteria:

• Age > 18 years with a clear cornea and clear ocular media
• BCVA ≥ 20/40
• Refractive error within ± 6.0 diopters (D) of 0 and astigmatism ± 3.0 D of 0

Exclusion Criteria:

• uveitis
• secondary glaucoma
• corneal abnormalities
• non-glaucomatous optic neuropathies
• previous trauma
• ocular surgery or laser treatment
• any other eye disease except glaucoma.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal subject; Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is within the normal range and those with no history of ocular disease, an intraocular pressure < 21 mmHg, an absence of glaucomatous optic disc appearance, and a normal visual field, they will be classified into normal group.	Diagnostic test: SD-OCT; SD-OCT was performed to all subjects to measure BMO-MRW and RNFL thickness by trained glaucoma specialist. It takes about 5 to 10 minutes. The foveal location was manually detected with a live B-scan, followed by defining BMO center. A radial pattern containing 24 angular, equidistant, high-resolution 15° B-scans centered on the BMO was used to compute the neuroretinal rim parameters. The BMO points and ILM were identified and marked in each B-scan with automated software (Glaucoma Module Premium Edition, version 6.0; Heidelberg Engineering). After radial scan completed, 3 consecutive circumpapillary B-scans were followed to measure RNFL thickness at diameter of 3.5, 4.1 and 4.7mm. BMO-MRW and RNFL thickness was automatically computed globally and sectorally.
Glaucoma patients; Measure BMO-MRW and RNFL with SD-OCT. If the BMO-MRW and RNFL is below the normal range and those with glaucomatous optic disc and two consecutive abnormal visual field test results with open angles on gonioscopy, glaucomatous optic neuropathy, RNFL defects congruent with visual field defects, they will be classified into glaucoma patients.	Diagnostic test: SD-OCT; SD-OCT was performed to all subjects to measure BMO-MRW and RNFL thickness by trained glaucoma specialist. It takes about 5 to 10 minutes. The foveal location was manually detected with a live B-scan, followed by defining BMO center. A radial pattern containing 24 angular, equidistant, high-resolution 15° B-scans centered on the BMO was used to compute the neuroretinal rim parameters. The BMO points and ILM were identified and marked in each B-scan with automated software (Glaucoma Module Premium Edition, version 6.0; Heidelberg Engineering). After radial scan completed, 3 consecutive circumpapillary B-scans were followed to measure RNFL thickness at diameter of 3.5, 4.1 and 4.7mm. BMO-MRW and RNFL thickness was automatically computed globally and sectorally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruch's membrane opening - minimum rim width (BMO-MRW)	SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.	5~10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber layer (RNFL) thickness	SD-OCT will be performed to the patients to measure RNFL thickness. This is measured at the same time as BMO-MRW, not separately.	5~10 minutes

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Jiwoong Lee, M.D., Ph.D, Medical Research Institute, Pusan National University Hospital, Busan, Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: OCT; Glaucoma; RNFL; BMO-MRW
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 1510-001-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participants data for all primary and secondary outcome measures will be shared.
• IPD Sharing Time Frame: Data will be available within 12 months after study published.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external independent review panel (PNUH IRB) and if they approve, data will be provided.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No