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

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT05104294
Collaborator
(none)
76
1
6.4
11.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
76 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma
Actual Study Start Date :
Feb 2, 2020
Actual Primary Completion Date :
Jul 14, 2020
Actual Study Completion Date :
Aug 15, 2020

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    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. [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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benha University Banhā Benha Egypt 13511

    Sponsors and Collaborators

    • Benha University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT05104294
    Other Study ID Numbers:
    • RC-9-11-01
    First Posted:
    Nov 2, 2021
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ahmed Abdelshafy, Lecturer of Ophthalmology, Benha University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 2, 2021