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

NCT03257020 | Completed DMC FDA Device

• 1 other identifier: 1510-001-034
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Tomography, Optical Coherence

Keywords

OCT; RNFL; BMO-MRW; Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Retinal nerve fiber layer (RNFL) thickness

  5~10 minutes

Study Arms (2)

Normal subject

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.

Diagnostic Test: SD-OCT

Glaucoma patients

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.

Diagnostic Test: SD-OCT

Interventions

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.

Glaucoma patients; Normal subject

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients who visited Pusan National University Hospital glaucoma clinic.

You may qualify if:

• 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

You may not qualify if:

• uveitis
• secondary glaucoma
• corneal abnormalities
• non-glaucomatous optic neuropathies
• previous trauma
• ocular surgery or laser treatment
• any other eye disease except glaucoma.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, 49214, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Jiwoong Lee, M.D., Ph.D

  Medical Research Institute, Pusan National University Hospital, Busan, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 22, 2017
• Study Start: August 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available within 12 months after study published.
• Access Criteria: Data access requests will be reviewed by an external independent review panel (PNUH IRB) and if they approve, data will be provided.

Locations

KR (1)