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OpenTrials
Completed

NCT Number: NCT05104294

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

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Benha University

Banhā, Benha, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Optical Coherence Tomography- Angiography

Diagnostic Test

Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.

Other names: OCT-A

Photopic negative response

Diagnostic Test

Both the implicit time and amplitude of PhNR were recorded.

Other names: PhNR

Primary outcomes

  1. Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.

    Time frame: 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 outcomes

  1. Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 2, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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