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

Completed
Conditions
Open Angle Glaucoma
Interventions
Diagnostic Test: Optical Coherence Tomography- Angiography
Diagnostic Test: Photopic negative response
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.

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
Arm && Interventions
GroupInterventionDescription
Control GroupOptical Coherence Tomography- Angiography80 eyes of 40 healthy subjects as control group.
mild Primary Open Angle Glaucoma group (Group I)Photopic negative response28 eyes of 16 patients with mild primary open angle glaucoma as group I.
Control GroupPhotopic negative response80 eyes of 40 healthy subjects as control group.
mild Primary Open Angle Glaucoma group (Group I)Optical Coherence Tomography- Angiography28 eyes of 16 patients with mild primary open angle glaucoma as group I.
moderate to severe Primary Open Angle Glaucoma group (Group II)Optical Coherence Tomography- Angiography44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II.
moderate to severe Primary Open Angle Glaucoma group (Group II)Photopic negative response44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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