High MyopiaNCT06596408
Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .
A study testing optical coherence tomography angiography in people with High Myopia, run by Sohag University at 1 site in Egypt.
Trial summary
Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA . Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- High Myopia
- What is being tested?
- optical coherence tomography angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2024to Oct 2025
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .
Who cannot join
- -History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
- Previous intraocular surgery or ocular injury .
- Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .
Trial locations and contacts
1 site in 1 country.
Islam Awny Ahmed, Ass. Prof contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, Sohag Governorate, 82524
About this study
Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .
Read the detailed description
Study Design : This is a cross sectional observational study , of about 50 patients attending ophthalmology outpatient clinic at Sohag Teaching Hospital .
Inclusion criteria :
All myopic patients with axial high myopia (-6 spherical refractive error or more) attending the ophthalmology outpatient clinic .
Exclusion criteria :
The exclusion criteria will include :
- History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
- Previous intraocular surgery or ocular injury .
- Any patient with pathological myopic maculopathy (epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy ) .
- Conditions
- High Myopia
- Being tested
- optical coherence tomography angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography angiographyOther
OCTA will be used to evaluate the macular vascular density and to exclude patients with pathological myopic maculopathy
| Study group | Role | What they receive |
|---|---|---|
| High Myopes of spherical error -6 and more . | Experimental | About 50 participants with high myopia will undergo evaluation of their macular vascular density using OCTA and also central macular thickness using OCT. Receives: Other: optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of evaluation of vascular density in high myopes
Correlation between macular vascular density in high myopes and their :
Uncorrected visual acuity in diopters . Best corrected visual acuity in diopters . Spherical equivalent refraction that measured through this equivalent (spherical error + 1/2 cylindrical error ) .
Central macular thickness in micrometers .
To see how does ischemia affects vision in high myopes .
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start11 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Mohamed, Sohag University
- Investigators
- Adham Salah Mohammed, lecturer, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596408
- Sponsor's protocol ID
- Vascular Density in high Myope
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .
- ClinicalTrials.gov ID
- NCT06596408
- Acronym / sponsor ID
- Vascular Density in high Myope
- Conditions
- High Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 11 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .
Detailed description
Study Design : This is a cross sectional observational study , of about 50 patients attending ophthalmology outpatient clinic at Sohag Teaching Hospital .
Inclusion criteria :
All myopic patients with axial high myopia (-6 spherical refractive error or more) attending the ophthalmology outpatient clinic .
Exclusion criteria :
The exclusion criteria will include :
- History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
- Previous intraocular surgery or ocular injury .
- Any patient with pathological myopic maculopathy (epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy ) .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Myopes of spherical error -6 and more . | Experimental | Other: optical coherence tomography angiographyAbout 50 participants with high myopia will undergo evaluation of their macular vascular density using OCTA and also central macular thickness using OCT. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .
Key exclusion criteria (3 listed)
- -History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
- Previous intraocular surgery or ocular injury .
- Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography angiographyOCTA will be used to evaluate the macular vascular density and to exclude patients with pathological myopic maculopathy | Other | High Myopes of spherical error -6 and more . |
Primary outcome
Outcome of evaluation of vascular density in high myopes
Time frame: 6 month
Correlation between macular vascular density in high myopes and their : Uncorrected visual acuity in diopters . Best corrected visual acuity in diopters . Spherical equivalent refraction that measured through this equivalent (spherical error + 1/2 cylindrical error ) . Central macular thickness in micrometers . To see how does ischemia affects vision in high myopes .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Islam Awny Ahmed, Ass. Prof contact
Adham Salah Mohammed, lecturer study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optical coherence tomography angiography in people with High Myopia, 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 3 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 19 Sep 2024. 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 Sara Magdy Mohammed, Master degree (00201096507733, saramagdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of evaluation of vascular density in high myopes (time frame: 6 month). 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 19 Sep 2024.