"Predicting Glaucoma Progression With Optical Coherence Tomography Structural and Angiographic Parameters".

• Conditions: Optical Coherence Tomography Glaucoma

• Registration Number: NCT04646122
• Lead Sponsor: Assiut University

Brief Summary

to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments

,and detection of optic disc perfusion changes using OCTA.

Detailed Description

Subjects will go a comprehensive ophthalmologic examination including review of medical history, best-corrected visual acuity (BCVA), slit-lamp biomicroscopy, intraocular pressure (IOP) measurement, gonioscopy, dilated fundoscopic examination, stereoscopic optic disc photography, and automated perimetry using Swedish Interactive Threshold Algorithm (SITA Standard 24-2). Only subjects with open angles on gonioscopy were included.

One eye of each subject will be scanned by a high-speed 1050-nm-wavelength swept-source OCT instrument.

OCT is providing measurements of the RNFL thickness, ONH, as well as the inner macula for the assessment of glaucoma progression.

The split-spectrum amplitude-decorrelation angiography (SSADA) algorithm will be used to compute 3-dimensional optic disc angiography. A disc flow index was computed from 4 registered scans.

Evaluation of progressive changes of the optic disc and RNFL will be based on event-analysis and/or trend-analysis. In event analysis, progression is defined when the difference between the baseline and follow-up measurements of the parameter of interest is greater than its test-retest variability (or the reproducibility coefficient). In trend analysis, regression analysis is performed between the parameter of interest and time.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-11-20
• Last Update Submitted: 2020-11-20
• Study First Posted: 2020-11-27
• Last Update Posted: 2020-11-27
• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
optic nerve head (ONH)	one year	Thickness using OCT
retinal nerve fiber layer RNFL	one year	Thickness using OCT

Secondary Outcome Measures

Name	Time	Method
disc perfusion changes	one year	flow index using OCTA