MyopiaNCT04135209
Optical Coherence Tomography Angiography in Myopic Patients
An observational study of Myopia, run by Minia University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Optical coherence tomography angiography OCTA
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jun 2019
- How long will I take part?
- 1 Day
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Groiup A patients were chosen when met the inclusion criteria. Group B individuals were chosen among healthy age-matched controls.
Who may be able to join
- • Highly myopic subjects, defined as those with spherical equivalents (SEs) of -6 or more, with axial length greater than 26.5 mm.
- Group B individuals were chosen among healthy age-matched controls.
Who cannot join
- • Patients younger than 18 years old, or older than 45 years.
- Any patient with macular pathology (e.g. diabetic retinopathy, hypertensive retinopathy, dystrophy)
- Myopic patients with any vitro-retinal abnormalities (e.g. choroidal neovascular membrane (CNVM), foveoschisis,macular hole)
- Patients who underwent previous intra ocular surgical procedures.
- Patients with previous history of intraocular injections.
- Glaucomatous patients.
Show all 11Show fewer
- - Low signal strength index (less than 50).
- - Presence of blink artefacts.
- - Poor fixation leading to motion or doubling artefacts.
- - Media opacity obscuring view of the vasculature.
- - Segmentation error due to cystoid macular oedema or epi-retinal membrane, among others.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography
The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.
Read the detailed description
High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the retina leads to sight threatening complications.
Quantitative measurements of retinal vasculature in the healthy eye have been reported using several in vivo and in vitro techniques, including confocal microscopy, fluorescein angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.
The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.
This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited from the outpatient clinic of ophthalmology department of El-Minia university hospital.They were divided into two groups, group A included 25 normal eyes of 25 patients. Group B included 50 myopic eyes of 30 patients.
All patients subjected to history taking and full ophthalmological examination in addition to axial length measurment before performing OCTA.
- Conditions
- Myopia
- Being tested
- Optical coherence tomography angiography OCTA
- Keywords
- Optical coherence tomography, Angiography, Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiography OCTADiagnostic test
Also called OCTA
Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Healthy individuals of age-matched Receives: Diagnostic Test: Optical coherence tomography angiography OCTA | |
| Myopic patients | Patients with myopia who meet the inclusion criteria Receives: Diagnostic Test: Optical coherence tomography angiography OCTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in angiography between the 2 groups
The difference of the volumetric data generated automatically from the OCTA machine at the 3 levels, (the inner retina, outer retina and the choriocapillaris) in three zones (the fovea, the parafovea and the whole image)
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Tarek A. Moustafa, Minia University
- Investigators
- M. Tarek A Mosutafa, MD, Principal investigator, Lecturer of ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135209
- Sponsor's protocol ID
- 68-7/2018
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04135209
- Acronym / sponsor ID
- 68-7/2018
- Conditions
- Myopia
- Keywords
- Optical coherence tomography, Angiography, Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 Oct 2019 (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 aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.
Detailed description
High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the retina leads to sight threatening complications.
Quantitative measurements of retinal vasculature in the healthy eye have been reported using several in vivo and in vitro techniques, including confocal microscopy, fluorescein angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.
The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.
This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited from the outpatient clinic of ophthalmology department of El-Minia university hospital.They were divided into two groups, group A included 25 normal eyes of 25 patients. Group B included 50 myopic eyes of 30 patients.
All patients subjected to history taking and full ophthalmological examination in addition to axial length measurment before performing OCTA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Optical coherence tomography angiography OCTAHealthy individuals of age-matched |
| Myopic patients | – | Diagnostic Test: Optical coherence tomography angiography OCTAPatients with myopia who meet the inclusion criteria |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Groiup A patients were chosen when met the inclusion criteria. Group B individuals were chosen among healthy age-matched controls.
Key inclusion criteria (2 listed)
- • Highly myopic subjects, defined as those with spherical equivalents (SEs) of -6 or more, with axial length greater than 26.5 mm.
- Group B individuals were chosen among healthy age-matched controls.
Key exclusion criteria (11 listed)
- • Patients younger than 18 years old, or older than 45 years.
- - Low signal strength index (less than 50).
- - Presence of blink artefacts.
- - Poor fixation leading to motion or doubling artefacts.
- - Media opacity obscuring view of the vasculature.
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 angiography OCTAAlso: OCTAMacular scanning using regular structural OCT as well as microvasculature analysis using OCTA | Diagnostic test | Healthy controls, Myopic patients |
Primary outcome
Difference in angiography between the 2 groups
Time frame: through study completion, an average of 4 weeks
The difference of the volumetric data generated automatically from the OCTA machine at the 3 levels, (the inner retina, outer retina and the choriocapillaris) in three zones (the fovea, the parafovea and the whole image)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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.
M. Tarek A Mosutafa, MD principal investigator
Lecturer of ophthalmology
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 Myopia, run by Minia 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 22 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in angiography between the 2 groups (time frame: through study completion, an average of 4 weeks). 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 22 Oct 2019.