Myopic Choroidal NeovascularisationNCT06357559
OCTA Changes in Choroidal Neovascularization in High Myopia
An observational study of Myopic Choroidal Neovascularisation, run by Sohag University.
Trial summary
To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. Read more about this study
- Who is it for?
- Ages 10 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopic Choroidal Neovascularisation
- What is being tested?
- OCTA
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 1 Dec 2024
- 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 10 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with High Myopia ( Refractive Error > -6D or Axial Length > 26,5 mm ) with Fundoscopic Changes Consistent with CNVM.
Who may be able to join
- All Patients with High Myopia ( > -6 D or Axial Length > 26.5 mm ) with Fundoscopic Changes Consistent with CNVM , with Clear Media are Subjected to OCTA
Who cannot join
- Patients with Treated CNVs , or with other Causes of CNVs including :
- Neovascular AMD , Idiopathic CNV , Traumatic , Inflammatory , Neoplastic , Degenerative ..
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence Tomography Angiography Changes in Choroidal Neovascularization in High Myopia
To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV..
Read the detailed description
To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. regarding the size , shape , core , margin , Appearance , and activity of CNV..
- Conditions
- Myopic Choroidal Neovascularisation
- Being tested
- OCTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTADevice
Optical Coherence Tomography Angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA
Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA Regarding its Activity ..
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopic Choroidal NeovascularisationStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hamdy Abdelrahman, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357559
- Sponsor's protocol ID
- OCTA in Myopic CNV
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ohno-Matsui K, Ikuno Y, Lai TYY, Gemmy Cheung CM. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018 Mar;63:92-106. doi: 10.1016/j.preteyeres.2017.10.005. Epub 2017 Oct 28.
PubMed 29111299
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Changes in Choroidal Neovascularization in High Myopia
- ClinicalTrials.gov ID
- NCT06357559
- Acronym / sponsor ID
- OCTA in Myopic CNV
- Conditions
- Myopic Choroidal Neovascularisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Apr 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.
To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV..
Detailed description
To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. regarding the size , shape , core , margin , Appearance , and activity of CNV..
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with High Myopia ( Refractive Error > -6D or Axial Length > 26,5 mm ) with Fundoscopic Changes Consistent with CNVM.
Key inclusion criteria (1 listed)
- All Patients with High Myopia ( > -6 D or Axial Length > 26.5 mm ) with Fundoscopic Changes Consistent with CNVM , with Clear Media are Subjected to OCTA
Key exclusion criteria (2 listed)
- Patients with Treated CNVs , or with other Causes of CNVs including :
- Neovascular AMD , Idiopathic CNV , Traumatic , Inflammatory , Neoplastic , Degenerative ..
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 |
|---|---|---|
| OCTAOptical Coherence Tomography Angiography | Device | – |
Primary outcome
Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA
Time frame: 1 year
Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA Regarding its Activity ..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 29111299Ohno-Matsui K, Ikuno Y, Lai TYY, Gemmy Cheung CM. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018 Mar;63:92-106. doi: 10.1016/j.preteyeres.2017.10.005. Epub 2017 Oct 28.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopic Choroidal Neovascularisation, run by Sohag University.
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 2 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 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Hamdy (01287307536, fcb9976@Gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06357559, which also lists 1 linked publication.
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 10 Apr 2024.