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

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

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.

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Diagnostic test: Optical Coherence Tomography- Angiography; Diagnostic test: Photopic negative response

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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• Egypt
  • Benha
    • Banhā, Benha, Egypt, 13511
      • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

One hundreds fifty-two eyes of 76 participants were included in this study, with the participants recruited from the outpatient glaucoma clinic of Benha University Hospital, EGYPT.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild Primary Open Angle Glaucoma group (Group I); 28 eyes of 16 patients with mild primary open angle glaucoma as group I.	Diagnostic test: Optical Coherence Tomography- Angiography; Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.; Other Names: OCT-A; Diagnostic test: Photopic negative response; Both the implicit time and amplitude of PhNR were recorded.; Other Names: PhNR
moderate to severe Primary Open Angle Glaucoma group (Group II); 44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II.	Diagnostic test: Optical Coherence Tomography- Angiography; Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.; Other Names: OCT-A; Diagnostic test: Photopic negative response; Both the implicit time and amplitude of PhNR were recorded.; Other Names: PhNR
Control Group; 80 eyes of 40 healthy subjects as control group.	Diagnostic test: Optical Coherence Tomography- Angiography; Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.; Other Names: OCT-A; Diagnostic test: Photopic negative response; Both the implicit time and amplitude of PhNR were recorded.; Other Names: PhNR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Study Chair: Marwa A Tabl, MD, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2020
• Primary Completion (Actual): July 14, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Optical coherence Tomography; Open angle glaucoma; Photopic negative response
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: RC-9-11-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No