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

Completed

• Conditions: Tomography, Optical Coherence; Glaucoma
• Interventions: Diagnostic Test: SD-OCT

• Registration Number: NCT03257020
• Lead Sponsor: Pusan National University Hospital

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Last Update Submitted: 2017-08-24
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal subject	SD-OCT	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.
Glaucoma patients	SD-OCT	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of