MyopiaNCT04631991
Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With OCTA
An observational study of Myopia, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myopia
- What is being tested?
- Comprehensive ophthalmologic examination
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2020to 8 Dec 2020
- 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 50 years
- All sexes
- Adult
Study population: Study population includes a convenience sampling from the patients admitted to outpatient clinic between November 2020 and December 2020.
Who may be able to join
- Patients with category 0 (no myopic retinopathy lesions)
- Patients with category 1 (tessellated fundus)
Who cannot join
- poor image quality (signal strength index (SSI) <60) due to unstable fixation
- IOP >21 mm Hg; logMAR > 0.1
- pre-existing ophthalmic pathologies
- prior ocular surgery
- systemic chronic disease which can cause retinopathy
- such as diabetes mellitus, hypertension etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Read the detailed description
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination, including measurements of best-corrected visual acuity, refractive error; intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination and OCTA imaging are included. The best-corrected visual acuity is convert into the logarithm of minimal angle resolution. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Right eye of each participant is included in the study. If the right eye shows any exclusion criteria, then the left eye is selected for enrollment. Eyes with an AL longer than 26 mm are included in the HM group. The classification of myopic maculopathy is applied in identification of fundus alterations. Patients with category 0 (no myopic retinopathy lesions) and category 1 (tessellated fundus) are included in the study.
- Conditions
- Myopia
- Being tested
- Comprehensive ophthalmologic examination
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive ophthalmologic examinationDiagnostic test
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
| Study group | Role | What they receive |
|---|---|---|
| Non-pathological high myopia | Comprehensive ophthalmologic examination Receives: Diagnostic Test: Comprehensive ophthalmologic examination | |
| Control | Comprehensive ophthalmologic examination Receives: Diagnostic Test: Comprehensive ophthalmologic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head vessel density
Optic nerve head vessel density assessed with optical coherence tomography angiography
Measured: 10 minutes
Secondary outcomes (4)
Choriocapillaris flow area
Choriocapillaris flow area assessed with optical coherence tomography angiography
Measured: 10 minutes
Subfoveal choroidal thickness
Subfoveal choroidal thickness assessed with optical coherence tomography angiography
Measured: 10 minutes
Foveal avascular zone
Foveal avascular zone assessed with optical coherence tomography angiography
Measured: 10 minutes
Subfoveal central macular thickness
Subfoveal central macular thickness assessed with optical coherence tomography angiography
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start10 Nov 2020
- Primary completion5 Dec 2020
- Study completion8 Dec 2020
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 MyopiaStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı Çetinkaya Yaprak, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631991
- Sponsor's protocol ID
- 18062020-167
- Status last verified
- Jan 2021
- First submitted
- 11 Nov 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yaprak AC, Yaprak L. Retinal microvasculature and optic disc alterations in non-pathological high myopia with optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3221-3227. doi: 10.1007/s00417-021-05216-x. Epub 2021 May 7.
PubMed 33961111
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Retinal Microvasculature and Optic Disc Alterations in Non-pathological High Myopia With Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT04631991
- Acronym / sponsor ID
- 18062020-167
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 17 Nov 2020 (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.
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination are included. The Optical Coherence Tomography Angiography (OCTA) software automatically segments these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Detailed description
Non-pathological high myopia patients and controls undergoing a comprehensive ophthalmologic examination, including measurements of best-corrected visual acuity, refractive error; intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination and OCTA imaging are included. The best-corrected visual acuity is convert into the logarithm of minimal angle resolution. The OCTA images are independently graded and assessed by two retinal specialists. The software automatically segmented these full-thickness retinal scans into the superficial and deep inner retinal vascular plexuses, outer retina, and choriocapillaris (CC). The vascular density in the superficial and deep retinal vascular zones is calculated automatically by the software, and the foveal avascular zone (FAZ) and foveal density (FD) are also automatically determined. Choroidal thickness is calculated manually by two retinal specialists, and the average value was used.
Right eye of each participant is included in the study. If the right eye shows any exclusion criteria, then the left eye is selected for enrollment. Eyes with an AL longer than 26 mm are included in the HM group. The classification of myopic maculopathy is applied in identification of fundus alterations. Patients with category 0 (no myopic retinopathy lesions) and category 1 (tessellated fundus) are included in the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pathological high myopia | – | Diagnostic Test: Comprehensive ophthalmologic examinationComprehensive ophthalmologic examination |
| Control | – | Diagnostic Test: Comprehensive ophthalmologic examinationComprehensive ophthalmologic examination |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Study population includes a convenience sampling from the patients admitted to outpatient clinic between November 2020 and December 2020.
Key inclusion criteria (2 listed)
- Patients with category 0 (no myopic retinopathy lesions)
- Patients with category 1 (tessellated fundus)
Key exclusion criteria (6 listed)
- poor image quality (signal strength index (SSI) <60) due to unstable fixation
- IOP >21 mm Hg; logMAR > 0.1
- pre-existing ophthalmic pathologies
- prior ocular surgery
- systemic chronic disease which can cause retinopathy
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 |
|---|---|---|
| Comprehensive ophthalmologic examinationMeasurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging. | Diagnostic test | Control, Non-pathological high myopia |
Primary outcome
Optic nerve head vessel density
Time frame: 10 minutes
Optic nerve head vessel density assessed with optical coherence tomography angiography
4 secondary outcomes
Choriocapillaris flow area
Time frame: 10 minutes
Subfoveal choroidal thickness
Time frame: 10 minutes
Foveal avascular zone
Time frame: 10 minutes
Subfoveal central macular thickness
Time frame: 10 minutes
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 14 Jan 2021.
- Derived from this study: PubMed 33961111Yaprak AC, Yaprak L. Retinal microvasculature and optic disc alterations in non-pathological high myopia with optical coherence tomography angiography. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3221-3227. doi: 10.1007/s00417-021-05216-x. Epub 2021 May 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Akdeniz University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 14 Jan 2021. 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 Turkey (Türkiye). 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?
Optic nerve head vessel density (time frame: 10 minutes). 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 NCT04631991, 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 14 Jan 2021.