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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04646122
Collaborator
(none)
100
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
"Predicting Glaucoma Progression With Optical Coherence Tomography Structural and Angiographic Parameters".
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Outcome Measures

Primary Outcome Measures

  1. retinal nerve fiber layer RNFL [one year]

    Thickness using OCT

  2. optic nerve head (ONH) [one year]

    Thickness using OCT

Secondary Outcome Measures

  1. disc perfusion changes [one year]

    flow index using OCTA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  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

  1. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed Fathallah, Phd, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Asmaa Ahmed Ali Youssif, Assiut, Assiut University
ClinicalTrials.gov Identifier:
NCT04646122
Other Study ID Numbers:
  • Glaucoma Progression with Opti
First Posted:
Nov 27, 2020
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 27, 2020