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

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.

Study Overview

• Status: Unknown
• Conditions: Optical Coherence Tomography Glaucoma
• Intervention / Treatment: Device: Optical Coherence Tomography

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

1. Inclusion criteria:

   • Patients older than 18 years of age with primary open-angle glaucoma (OAG) .
   • Primary OAG (POAG) diagnosed on the basis of IOP measurements more than 21 mmHg, open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width), glaucomatous visual field defects consistent with glaucomatous optic disc changes.
   • Eyes with baseline macular and ONH OCT images and ONH photographs of adequate quality and r performed within 6 months of each other were selected

2. Exclusion criteria:

   • Participants with significant retinal disease.
   • non-glaucomatous optic neuropathy.
   • anomalous discs
   • any retinal pathology. A history of cataract or glaucoma surgery will not be exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retinal nerve fiber layer RNFL	Thickness using OCT	one year
optic nerve head (ONH)	Thickness using OCT	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disc perfusion changes	flow index using OCTA	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ahmed Fathallah, Phd, Assiut University

Publications and helpful links

General Publications

• Bussel II, Wollstein G, Schuman JS. OCT for glaucoma diagnosis, screening and detection of glaucoma progression. Br J Ophthalmol. 2014 Jul;98 Suppl 2(Suppl 2):ii15-9. doi: 10.1136/bjophthalmol-2013-304326. Epub 2013 Dec 19.
• Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: November 15, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (ACTUAL): November 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Glaucoma Progression with Opti

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No