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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257020
• Other study ID #: 1510-001-034
• Status: Completed
• Phase: N/A
• First received: August 17, 2017
• Last updated: August 24, 2017
• Start date: August 1, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2017
• Source: Pusan National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Tomography, Optical Coherence

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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