NCT03257020

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
• Phase: —
• Study type: Observational
• Enrollment: 402 (actual)
• Sponsor: Pusan National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

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.

Conditions

• Glaucoma
• Tomography, Optical Coherence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2017-08-22
• Last updated: 2017-08-25

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study