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

Optical Coherence Tomography Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04646122
• Other study ID #: Glaucoma Progression with Opti
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: Asmaa Ali, MD
• Phone: 01002475442
• Email: asmaaahmedali[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Optical Coherence Tomography Glaucoma

Intervention

Device:
• Optical Coherence Tomography
Optical Coherence Tomography parameters

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Bussel II, Wollstein G, Schuman JS. OCT for glaucoma diagnosis, screening and detection of glaucoma progression. Br J Ophthalmol. 2014 Jul;98 Suppl 2:ii15-9. doi: 10.1136/bjophthalmol-2013-304326. Epub 2013 Dec 19. Review. — View Citation

Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retinal nerve fiber layer RNFL	Thickness using OCT	one year
Primary	optic nerve head (ONH)	Thickness using OCT	one year
Secondary	disc perfusion changes	flow index using OCTA	one year