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NCT Number: NCT03257020

The Diagnostic Performance of BMO-MRW and RNFL 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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Tomography, Optical Coherence

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hospital

Busan, 49214, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SD-OCT

Diagnostic Test

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.

Primary outcomes

  1. Bruch's membrane opening - minimum rim width (BMO-MRW)

    Time frame: 5~10 minutes

    SD-OCT will be performed to the patients to measure BMO-MRW by trained glaucoma specialist.

Secondary outcomes

  1. Retinal nerve fiber layer (RNFL) thickness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2017
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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