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

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104294
• Other study ID #: RC-9-11-01
• Status: Completed
• Start date: February 2, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: October 2021
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 15, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Diagnostic Test:
• Optical Coherence Tomography- Angiography
Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.
• Photopic negative response
Both the implicit time and amplitude of PhNR were recorded.

Locations

Country	Name	City	State
Egypt	Benha University	Banha	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.