Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma

May 11, 2025 updated by: Miadaa Hassan Hassaneen, Assiut University

Correlation Between Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma

This study aimed to assess the correlation between visual field changes and optical coherence tomography (OCT) angiography changes of retinal nerve fiber layer in patients with primary open angle glaucoma.

Study Overview

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide. Since glaucomatous damage is preventable but irreversible, an early diagnosis and close follow-up of glaucoma patients are primordial. Optical coherence tomography angiography (OCTA) is a recently developed, noninvasive imaging modality that detects blood flow through the motion contrast generated by red blood cells.

Currently, there are 2 groups of complementary exams used for the diagnosis and follow-up of glaucoma patients: structural (where OCT has a considerable role) and functional (visual field) optic nerve measurements, Both technologies have strengths and limitations.

A new technology for diagnosis and follow-up that can avoid the limitations summarized above is lacking. OCTA seems to be a good candidate for such a role, OCT can detect the Doppler frequency shift of the backscattered light that provides information on blood flow.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, 71515
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This prospective cohort nonrandomized trial was carried out on 100 cases with primary open-angle glaucoma (POAG) group (n=80): had intraocular pressure (IOP)>21 mmHg, and control group (n=20): without family history of POAG, IOP ˂21mm Hg.

Description

Inclusion Criteria:

  • Primary open angle glaucoma patients.

Exclusion Criteria:

  1. Hazy media.
  2. Diabetic Retinopathy.
  3. Uveitis.
  4. Other Glaucomas

    • Acute congestive glaucoma
    • Secondary glaucomas

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POAG group
Patients had intraocular pressure (IOP)>21 mmHg,
Patients had intraocular pressure (IOP)>21 mmHg.
Control group
Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.
Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripapillary vessel density (PpVD)
Time Frame: 12 months post-procedure

Peripapillary vessel density (PpVD) was examined with swept-source OCT(DRI OCT Triton;Topcon Corporation,Tokyo,Japan) after pupillary dilatation , using an optic disc scan , peripapillary vessel density was derived from the images acquired with a 6 mm x6 mm mm field of view centered on the optic disc.

PpVD measurements were calculated within the RNFL in a slab from the internal limiting membrane (ILM) to the RNFL posterior boundary.

12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern standard deviation (PSD)
Time Frame: 12 months post-procedure
Pattern standard deviation ( PSD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
12 months post-procedure
Mean deviation (MD)
Time Frame: 12 months post-procedure
Mean deviation(MD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
12 months post-procedure
The thickness of the peripapillary retinal nerve fiber layer(RNFL)
Time Frame: 12 months post-procedure

The thickness of the peripapillary retinal nerve fiber layer(RNFL) was obtained from a circle with a diameter of 3.4 mm centered on the optic disc.

The RNFL thickness in 4 quadrants and 12 clock-hour were obtained by using the built-in automated segmentation algorism of the system.

12 months post-procedure
Intraocular pressure (IOP)
Time Frame: 12 months post-procedure
Intraocular pressure (IOP) was recorded.
12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

May 11, 2025

First Submitted That Met QC Criteria

May 11, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 11, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MD/AZ.AST./OPH026/10/191/1/202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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