- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06978101
- Original Trial
Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma
Correlation Between Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide. Since glaucomatous damage is preventable but irreversible, an early diagnosis and close follow-up of glaucoma patients are primordial. Optical coherence tomography angiography (OCTA) is a recently developed, noninvasive imaging modality that detects blood flow through the motion contrast generated by red blood cells.
Currently, there are 2 groups of complementary exams used for the diagnosis and follow-up of glaucoma patients: structural (where OCT has a considerable role) and functional (visual field) optic nerve measurements, Both technologies have strengths and limitations.
A new technology for diagnosis and follow-up that can avoid the limitations summarized above is lacking. OCTA seems to be a good candidate for such a role, OCT can detect the Doppler frequency shift of the backscattered light that provides information on blood flow.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary open angle glaucoma patients.
Exclusion Criteria:
- Hazy media.
- Diabetic Retinopathy.
- Uveitis.
Other Glaucomas
- Acute congestive glaucoma
- Secondary glaucomas
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
POAG group
Patients had intraocular pressure (IOP)>21 mmHg,
|
Patients had intraocular pressure (IOP)>21 mmHg.
|
|
Control group
Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.
|
Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peripapillary vessel density (PpVD)
Time Frame: 12 months post-procedure
|
Peripapillary vessel density (PpVD) was examined with swept-source OCT(DRI OCT Triton;Topcon Corporation,Tokyo,Japan) after pupillary dilatation , using an optic disc scan , peripapillary vessel density was derived from the images acquired with a 6 mm x6 mm mm field of view centered on the optic disc. PpVD measurements were calculated within the RNFL in a slab from the internal limiting membrane (ILM) to the RNFL posterior boundary. |
12 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pattern standard deviation (PSD)
Time Frame: 12 months post-procedure
|
Pattern standard deviation ( PSD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
|
12 months post-procedure
|
|
Mean deviation (MD)
Time Frame: 12 months post-procedure
|
Mean deviation(MD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
|
12 months post-procedure
|
|
The thickness of the peripapillary retinal nerve fiber layer(RNFL)
Time Frame: 12 months post-procedure
|
The thickness of the peripapillary retinal nerve fiber layer(RNFL) was obtained from a circle with a diameter of 3.4 mm centered on the optic disc. The RNFL thickness in 4 quadrants and 12 clock-hour were obtained by using the built-in automated segmentation algorism of the system. |
12 months post-procedure
|
|
Intraocular pressure (IOP)
Time Frame: 12 months post-procedure
|
Intraocular pressure (IOP) was recorded.
|
12 months post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD/AZ.AST./OPH026/10/191/1/202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Open Angle Glaucoma
-
Omar SaidCompletedGlaucoma,Primary Open-Angle ,Primary Angle ClosureEgypt
-
Henry Ford Health SystemNot yet recruitingPrimary Open Angle Glaucoma (POAG) | Secondary Open Angle Glaucoma | Open Angle Glaucoma (OAG)United States
-
Peking UniversityRecruitingPrimary Open Angle Glaucoma | Ocular Hypertension | Primary Open Angle Glaucoma of Both Eyes | Primary Open-Angle Glaucoma, Unspecified Eye | Suspect GlaucomaChina
-
Glaucot Teknoloji Anonim SirketiCompletedPrimary Open-Angle GlaucomaTurkey
-
China Medical University HospitalCompletedEffect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle GlaucomaPrimary Open-angle GlaucomaTaiwan
-
InnFocus Inc.CompletedPrimary Open-angle GlaucomaSpain, United States, United Kingdom, France, Italy
-
Glaukos CorporationTerminatedPrimary Open-Angle GlaucomaUnited States
-
Rehab mahmoud abdelhamid mohamedCairo UniversityCompletedPrimary Open-angle GlaucomaEgypt
-
Cairo UniversityUniversity of LuebeckUnknown
-
Xiaodong ZhouCompletedPrimary Open-angle Glaucoma
Clinical Trials on POAG group
-
Tanta UniversityCompletedChildren | Dexmedetomidine | Adenotonsillectomy | MidazolamEgypt
-
Tanta UniversityNot yet recruitingMelatonin | Doxorubicin | Vitamin D Concentration | Breast Cancer Patients DiagnosedEgypt
-
Charite University, Berlin, GermanyDepartment of Neurology, Charité - Universitätsmedizin Berlin, Germany; Department...Unknown
-
Raed SalimCompleted
-
University of Sao Paulo General HospitalCompletedOsteoarthritis, Knee
-
National Yang Ming Chiao Tung UniversityCompleted
-
Cairo UniversityCompleted
-
Al-Azhar UniversityCompleted
-
Zagazig UniversityCompleted
-
Riphah International UniversityCompleted