Primary Open Angle GlaucomaNCT05351307
Retinal Vascular Changes in Primary Open Angle Glaucoma Patients
An observational study of Primary Open Angle Glaucoma, run by Sohag University at 1 site in Egypt.
Trial summary
the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: > 18 years primary open angle glaucoma patients
Who may be able to join
- (> 18 years old)
Who cannot join
- patients with cataract
- retinal disorders including: AMD , Macular degeneration , retinal detachment , retinitis pigmentosa , etc .
- corneal opacites
- any ocular surgeries
- patients with systemic disease.
- patient refusal
Trial locations and contacts
1 site in 1 country.
Ismail Moussa Abd-Elatif, Professor contact
About this study
the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field.
Read the detailed description
Our study will be designed as " prospective non-randomized case - control study" The study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with POAG To detect ischemic changes in macula using OCT angiography correlating with glaucoma staging system II by visual field.
- Conditions
- Primary Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POAG patients | OCT angiography will be performed | |
| Normal participants | OCT angiography will be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic changes in macula
Using OCT angiography to detect ischemic changes in macula
Measured: Through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Hamza Ali, Sohag University
- Investigators
- Mohamed Iqbal Hafez, Assist prof, Study director, SupervisorHany Mahmoud Abdel Hamid, Lecturer, Study director, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351307
- Sponsor's protocol ID
- Soh-Med-22-03-03
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vascular Changes in Primary Open Angle Glaucoma Patients
- ClinicalTrials.gov ID
- NCT05351307
- Acronym / sponsor ID
- Soh-Med-22-03-03
- Conditions
- Primary Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study aims to detect ischemic changes in macula using OCT angiography in primary open angle glaucoma patients correlating with glaucoma staging system II by visual field.
Detailed description
Our study will be designed as " prospective non-randomized case - control study" The study will include 100 eyes of 100 participants 50 eyes of normal subjects , non-glaucomatous subjects 50 eyes of 50 patients with POAG To detect ischemic changes in macula using OCT angiography correlating with glaucoma staging system II by visual field.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAG patients | – | –OCT angiography will be performed |
| Normal participants | – | –OCT angiography will be performed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- > 18 years primary open angle glaucoma patients
Key inclusion criteria (1 listed)
- (> 18 years old)
Key exclusion criteria (6 listed)
- patients with cataract
- retinal disorders including: AMD , Macular degeneration , retinal detachment , retinitis pigmentosa , etc .
- corneal opacites
- any ocular surgeries
- patients with systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ischemic changes in macula
Time frame: Through one year
Using OCT angiography to detect ischemic changes in macula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail Moussa Abd-Elatif, Professor contact
Mohamed Iqbal Hafez, Assist prof study director
Supervisor
Hany Mahmoud Abdel Hamid, Lecturer study director
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Hamza, Resident (01018421051, Marwahamza12@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic changes in macula (time frame: Through one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.