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

NCT06978101 | Completed

• 1 other identifier: MD/AZ.AST./OPH026/10/191/1/202
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Field; OCT Angiography; Chorioretinal Changes; Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Peripapillary vessel density (PpVD)

  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 Outcomes (4)

• Pattern standard deviation (PSD)

  12 months post-procedure

• Mean deviation (MD)

  12 months post-procedure

• The thickness of the peripapillary retinal nerve fiber layer(RNFL)

  12 months post-procedure

• Intraocular pressure (IOP)

  12 months post-procedure

Study Arms (2)

POAG group

Patients had intraocular pressure (IOP)\>21 mmHg,

Other: POAG group

Control group

Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.

Other: Control group

Interventions

POAG group OTHER

Patients had intraocular pressure (IOP)\>21 mmHg.

POAG group

Control group OTHER

Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Primary open angle glaucoma patients.

You may not qualify if:

• Hazy media.
• Diabetic Retinopathy.
• Uveitis.
• Other Glaucomas
• Acute congestive glaucoma
• Secondary glaucomas

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Ophthalmology Department, Al-Azhar Faculty of Medicine in Assiut.

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: December 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)