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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03257020
Enrollment
402
Registered
2017-08-22
Start date
2015-08-01
Completion date
2016-12-31
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Tomography, Optical Coherence

Keywords

OCT, RNFL, BMO-MRW, Glaucoma

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTSD-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.

Sponsors

Pusan National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Bruch's membrane opening - minimum rim width (BMO-MRW)5~10 minutesSD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.

Secondary

MeasureTime frameDescription
Retinal nerve fiber layer (RNFL) thickness5~10 minutesSD-OCT will be performed to the patients to measure RNFL thickness. This is measured at the same time as BMO-MRW, not separately.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026