NCT04646122

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

November 15, 2020

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

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: 24357497BACKGROUND
  • 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.

    PMID: 16488940BACKGROUND

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Ahmed Fathallah, Phd

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Khaled Abdelazeem, Phd

CONTACT

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