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

P

Pusan National University

Status

Completed

Conditions

Glaucoma
Tomography, Optical Coherence

Treatments

Diagnostic Test: SD-OCT

Study type

Observational

Funder types

Other

Identifiers

NCT03257020
1510-001-034

Details and patient eligibility

About

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.

Full 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.

Enrollment

402 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

402 participants in 2 patient groups

Normal subject
Description:
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.
Treatment:
Diagnostic Test: SD-OCT
Glaucoma patients
Description:
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.
Treatment:
Diagnostic Test: SD-OCT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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