Eye DiseasesNCT05211089
Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment OCT
An observational study of Eye Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
The choroid, which is located between the retina and the sclera, is a connective tissue layer that is densely packed with blood vessels and is responsible for supplying oxygen and nutrients to the retina's periphery. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Optical Coherence Tomography imaging of choroid
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Jan 2022
- 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
- Adult
Study population: Normal adult volunteers
Who may be able to join
- Normal adult volunteers
Who cannot join
- Eyes with chorioretinal or vitreoretinal diseases
- History of intraocular surgery
- Glaucoma.
- Systemic diseases or conditions that could affect retinal or choroidal thickness,
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment Optical Coherence Tomography
The choroid, which is located between the retina and the sclera, is a connective tissue layer that is densely packed with blood vessels and is responsible for supplying oxygen and nutrients to the retina's periphery. One of the primary functions of the choroid is to support the metabolism of the retinal pigment epithelium (RPE). It is implicated in the pathogenesis of a variety of retinal disorders, including age-related macular degeneration, polypoidal choroidal vasculopathy, central serous chorioretinopathy, and high myopia-associated chorio retinal atrophies. Because choroidal alteration has a fundamental role in the development and progression of these diseases, choroidal thickness provides comprehensive information to physicians.
For the study of the choroid, researchers have used ultrasound, magnetic resonance imaging MRI, and Doppler laser, but these methods have limited utility due to a lack of resolution. Contrary to this, indocyanine green (ICG) angiography provides valuable clinical information but does not provide cross-sectional images of the choroid for in vivo research studies.
Read more
Optical coherence tomography (OCT) has gained in popularity in clinical and experimental ophthalmology over the last decade as a way to acquire detailed, three-dimensional images of the retina . Imaging the entire choroid, on the other hand, has proven to be more difficult due to the significant decline in signal strength beyond the RPE prompted by the pigment in the RPE and choroid and light scattering in the vasculature. The development of improved depth imaging (EDI) by Spaide et al. opened the door to quantitative choroid assessment. Choroid imaging is currently possible using one of two optical coherence tomography (OCT) techniques: (1) spectral-domain (SD) OCT utilizing standard light sources using EDI, and (2) swept-source (SS) OCT using a long wavelength light .A 1 m-band light source is used in SS-OCT, which penetrates deeper into the retino choroidal tissues and so optimizes the resolution. To better visualize retinal and choroidal changes, SS-OCT can concurrently display a focused image of both the retina and the choroid. This renders it an accurate technology for assessing choroidal thickness.
Such findings of choroidal thickness changes revealed that the choroid and choroidal thickness may be important attributes in the evaluation of ocular pathology. To properly understand the scientific value of these potential choroidal thickness variations, it would appear that comprehensive and systematic normative values for choroidal thickness are fundamental.
- Conditions
- Eye Diseases
- Being tested
- Optical Coherence Tomography imaging of choroid
- Keywords
- Choroidal thickness, Swept source, OCT
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography imaging of choroidOther
A single expert retinal specialists used a Topcon DRI-1 SS-OCT to do the Choroidal Thickness measurements. A 12, 9-mm radial line scan procedure was performed. Each radial line was automatically scanned 32 times in the same spot, followed by the creation of 12 high-resolution average B-scan images. Each scan was double-checked to confirm that it was centred on the fovea. Only scans of good quality were included. The perpendicular distance between the outer border of the RPE and the junction of the choroid and sclera was used to calculate CT. It was calculated automatically using the mapping software incorporated into the device and displayed as a colourful topographic map with nine subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) style grid.
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Manual and automated measurement of choroidal thickness
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211089
- Sponsor's protocol ID
- 17300719
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Versus Automated Choroidal Thickness Measurements Using Swept-source Anterior Segment Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05211089
- Acronym / sponsor ID
- 17300719
- Conditions
- Eye Diseases
- Keywords
- Choroidal thickness, Swept source, OCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Jan 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 choroid, which is located between the retina and the sclera, is a connective tissue layer that is densely packed with blood vessels and is responsible for supplying oxygen and nutrients to the retina's periphery. One of the primary functions of the choroid is to support the metabolism of the retinal pigment epithelium (RPE). It is implicated in the pathogenesis of a variety of retinal disorders, including age-related macular degeneration, polypoidal choroidal vasculopathy, central serous chorioretinopathy, and high myopia-associated chorio retinal atrophies. Because choroidal alteration has a fundamental role in the development and progression of these diseases, choroidal thickness provides comprehensive information to physicians.
For the study of the choroid, researchers have used ultrasound, magnetic resonance imaging MRI, and Doppler laser, but these methods have limited utility due to a lack of resolution. Contrary to this, indocyanine green (ICG) angiography provides valuable clinical information but does not provide cross-sectional images of the choroid for in vivo research studies.
Optical coherence tomography (OCT) has gained in popularity in clinical and experimental ophthalmology over the last decade as a way to acquire detailed, three-dimensional images of the retina . Imaging the entire choroid, on the other hand, has proven to be more difficult due to the significant decline in signal strength beyond the RPE prompted by the pigment in the RPE and choroid and light scattering in the vasculature. The development of improved depth imaging (EDI) by Spaide et al. opened the door to quantitative choroid assessment. Choroid imaging is currently possible using one of two optical coherence tomography (OCT) techniques: (1) spectral-domain (SD) OCT utilizing standard light sources using EDI, and (2) swept-source (SS) OCT using a long wavelength light .A 1 m-band light source is used in SS-OCT, which penetrates deeper into the retino choroidal tissues and so optimizes the resolution. To better visualize retinal and choroidal changes, SS-OCT can concurrently display a focused image of both the retina and the choroid. This renders it an accurate technology for assessing choroidal thickness.
Such findings of choroidal thickness changes revealed that the choroid and choroidal thickness may be important attributes in the evaluation of ocular pathology. To properly understand the scientific value of these potential choroidal thickness variations, it would appear that comprehensive and systematic normative values for choroidal thickness are fundamental.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Normal adult volunteers
Key inclusion criteria (1 listed)
- Normal adult volunteers
Key exclusion criteria (5 listed)
- Eyes with chorioretinal or vitreoretinal diseases
- History of intraocular surgery
- Glaucoma.
- Systemic diseases or conditions that could affect retinal or choroidal thickness,
- Pregnant women
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 imaging of choroidA single expert retinal specialists used a Topcon DRI-1 SS-OCT to do the Choroidal Thickness measurements. A 12, 9-mm radial line scan procedure was performed. Each radial line was automatically scanned 32 times in the same spot, followed by the creation of 12 high-resolution average B-scan images. Each scan was double-checked to confirm that it was centred on the fovea. Only scans of good quality were included. The perpendicular distance between the outer border of the RPE and the junction of the choroid and sclera was used to calculate CT. It was calculated automatically using the mapping software incorporated into the device and displayed as a colourful topographic map with nine subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) style grid. | Other | – |
Primary outcome
Choroidal thickness
Time frame: 1 day
Manual and automated measurement of choroidal thickness
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 27 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Eye Diseases
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
RecruitingObservational study
Clinical and Molecular Studies in Families With Inherited Eye Disease
Inherited Eye Disease
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
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 Eye Diseases, run by Assiut 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 5 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 27 Jan 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?
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?
Choroidal thickness (time frame: 1 day). 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 27 Jan 2022.