Clinical trial NCT05104294: Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma
Official title: Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: Open angle glaucoma
Optical coherence Tomography
Photopic negative response
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 76
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.
timeFrame: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
Secondary outcomes:
measure: Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.
timeFrame: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Benha
Study officials:
affiliation: Benha University
name: Marwa A Tabl, MD
role: STUDY_CHAIR
References: