Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma

Completed

• Conditions: Open Angle Glaucoma

• Registration Number: NCT05104294
• Lead Sponsor: Benha University

Brief Summary

Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.

Detailed Description

Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.

OCT Angiography (OCTA) is a promising tool for diagnosing and monitoring glaucomatous patients. It can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina Correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (RNFL) and macular/ganglion cell complex (GCC) can lead to early detection of glaucomatous changes.

Study Timeline

• Study Start: 2020-02-02
• Primary Completion: 2020-07-14
• Study Completion: 2020-08-15
• Status Verified: 2021-10
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-29
• Last Update Submitted: 2021-10-29
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Age of 30 years or older for both control and glaucoma groups.
• Spherical equivalent (SE) between -2 and +2 D.
• No history of previous eye surgery, trauma, or systemic diseases.

Exclusion Criteria

• Spherical equivalent greater than +/- 2.00 diopters (D).
• Media opacity as (cataract or corneal scar).
• Any history of ocular surgeries or trauma.
• Optic nerve anomaly or other retinal diseases.
• Unreliable visual field tests (33% fixation losses, false positive, and false- negative results).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.	Immediately after OCTA and electroretinogram diagnostic tests for each eye.	Correlation between RNFL thickness and GCC measured by OCT-A with implicit time and amplitude of Photopic Negative Response (PhNR) measured by electroretinogram.

Secondary Outcome Measures

Name	Time	Method
Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.	Immediately after OCTA and electroretinogram diagnostic tests for each eye.	Changes in the parameters were measured by OCT-A as Superficial and deep vessel Density.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, Benha, Egypt