"Predicting Glaucoma Progression With Optical Coherence Tomography Structural and Angiographic Parameters".
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2020
CompletedFirst Posted
Study publicly available on registry
November 27, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedNovember 27, 2020
November 1, 2020
1 year
November 15, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
retinal nerve fiber layer RNFL
Thickness using OCT
one year
optic nerve head (ONH)
Thickness using OCT
one year
Secondary Outcomes (1)
disc perfusion changes
one year
Interventions
Optical Coherence Tomography parameters
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Participants with significant retinal disease.
- non-glaucomatous optic neuropathy.
- anomalous discs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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(Suppl 2):ii15-9. doi: 10.1136/bjophthalmol-2013-304326. Epub 2013 Dec 19.
PMID: 24357497BACKGROUNDQuigley 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.
PMID: 16488940BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Fathallah, Phd
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assiut
Study Record Dates
First Submitted
November 15, 2020
First Posted
November 27, 2020
Study Start
January 1, 2021
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
November 27, 2020
Record last verified: 2020-11