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

NCT ID: NCT05104294

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-02

Study Completion Date

2020-08-15

Brief Summary

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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

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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.

Conditions

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Open Angle Glaucoma

Keywords

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Open angle glaucoma Optical coherence Tomography Photopic negative response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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mild Primary Open Angle Glaucoma group (Group I)

28 eyes of 16 patients with mild primary open angle glaucoma as group I.

Optical Coherence Tomography- Angiography

Intervention Type DIAGNOSTIC_TEST

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

Photopic negative response

Intervention Type DIAGNOSTIC_TEST

Both the implicit time and amplitude of PhNR were recorded.

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.

Optical Coherence Tomography- Angiography

Intervention Type DIAGNOSTIC_TEST

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

Photopic negative response

Intervention Type DIAGNOSTIC_TEST

Both the implicit time and amplitude of PhNR were recorded.

Control Group

80 eyes of 40 healthy subjects as control group.

Optical Coherence Tomography- Angiography

Intervention Type DIAGNOSTIC_TEST

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

Photopic negative response

Intervention Type DIAGNOSTIC_TEST

Both the implicit time and amplitude of PhNR were recorded.

Interventions

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Optical Coherence Tomography- Angiography

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

Intervention Type DIAGNOSTIC_TEST

Photopic negative response

Both the implicit time and amplitude of PhNR were recorded.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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OCT-A PhNR

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelshafy

Lecturer of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa A Tabl, MD

Role: STUDY_CHAIR

Benha University

Locations

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Benha University

Banhā, Benha, Egypt

Site Status

Countries

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Egypt

References

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Tabl AA, Tabl MA. Correlation between OCT-angiography and photopic negative response in patients with primary open angle glaucoma. Int Ophthalmol. 2023 Jun;43(6):1889-1901. doi: 10.1007/s10792-022-02588-9. Epub 2022 Nov 28.

Reference Type DERIVED
PMID: 36441346 (View on PubMed)

Other Identifiers

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RC-9-11-01

Identifier Type: -

Identifier Source: org_study_id