NCT05104294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

October 20, 2021

Last Update Submit

October 29, 2021

Conditions

Open Angle Glaucoma

Keywords

Open angle glaucomaOptical coherence TomographyPhotopic negative response

Outcome Measures

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.

    Correlation between RNFL thickness and GCC measured by OCT-A with implicit time and amplitude of Photopic Negative Response (PhNR) measured by electroretinogram.

    Immediately after OCTA and electroretinogram diagnostic tests for each eye.

Secondary Outcomes (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.

Study Arms (3)

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- AngiographyDiagnostic Test: Photopic negative response

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- AngiographyDiagnostic Test: Photopic negative response

Control Group

80 eyes of 40 healthy subjects as control group.

Diagnostic Test: Optical Coherence Tomography- AngiographyDiagnostic Test: Photopic negative response

Interventions

Optical Coherence Tomography- AngiographyDIAGNOSTIC_TEST

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

Also known as: OCT-A
Control Groupmild Primary Open Angle Glaucoma group (Group I)moderate to severe Primary Open Angle Glaucoma group (Group II)
Photopic negative responseDIAGNOSTIC_TEST

Both the implicit time and amplitude of PhNR were recorded.

Also known as: PhNR
Control Groupmild Primary Open Angle Glaucoma group (Group I)moderate to severe Primary Open Angle Glaucoma group (Group II)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, Benha, 13511, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 36441346DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Marwa A Tabl, MD

    Benha University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

February 2, 2020

Primary Completion

July 14, 2020

Study Completion

August 15, 2020

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)