NCT06434155

Brief Summary

The objective of this study is 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 20, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

GlaucomaOCT

Outcome Measures

Primary Outcomes (1)

  • OCT structural parameters

    RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT

    6 months

Study Arms (1)

Primary Open Angle Glaucoma

1. Patients older than 18 years of age with primary open-angle glaucoma (POAG) 2. 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. 3. 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients older than 18 years of age with primary open-angle glaucoma (OAG)

You may qualify if:

  • 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 photograps

You may not qualify if:

  • Participants with significant retinal disease.
  • non-glaucomatous optic neuropathy.
  • anomalous discs
  • any retinal pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 30, 2024

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations