Open Angle Glaucoma Clinical Trial
Official title:
Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma
NCT number | NCT05104294 |
Other study ID # | RC-9-11-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2, 2020 |
Est. completion date | August 15, 2020 |
Verified date | October 2021 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 76 |
Est. completion date | August 15, 2020 |
Est. primary completion date | July 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 55 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha University | Banha | Benha |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes. | Changes in the parameters were measured by OCT-A as Superficial and deep vessel Density. | Immediately after OCTA and electroretinogram diagnostic tests for each eye. |
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