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

Completed

• Conditions: Visual Field; OCT Angiography; Chorioretinal Changes; Primary Open Angle Glaucoma

• Registration Number: NCT06978101
• Lead Sponsor: Assiut University

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.

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 Timeline

• Study Start: 2021-12-30
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-11
• Last Update Submitted: 2025-05-11
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripapillary vessel density (PpVD)	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.

Secondary Outcome Measures

Name	Time	Method
Pattern standard deviation (PSD)	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.
Mean deviation (MD)	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.
The thickness of the peripapillary retinal nerve fiber layer(RNFL)	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.
Intraocular pressure (IOP)	12 months post-procedure	Intraocular pressure (IOP) was recorded.

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt