ESRDNCT03542448
Choroidal Thickness in Myopes by SSOCT
An observational study of ESRD, run by Assiut University at 1 site in Egypt.
Trial summary
Optical coherence tomography is a non-invasive and non-contact imaging modality that enables two-dimensional cross-sectional and three-dimensional volumetric imaging of tissue architecture. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- ESRD
- What is being tested?
- Swept source optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2017to 31 Mar 2018
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 100 case of age from 18 to 40 years old of myopic refraction from zero to -8 diopter , minimum corneal thickness from 500 to 540 micrometer , refractive power of cornea more than 41 diopter and axial length from 22 to 26 millimeter
Who may be able to join
- Age from 18 years to 40 age.
- Spherical equivalent from zero to -8.
- Minimum corneal thickness from 500 to 540.
- Refractive power of cornea more than 41 diopter.
- Axial length from 22 to 26.
Who cannot join
- Corneal abnormalities such as ectasia.
- Eyes with dystrophic or degenerative diseases.
- Prior ocular surgery.
- Anterior or posterior segment inflammation.
- Glaucoma.
- Eyes with choroidal abnormalities or conditions that could affect choroidal thickness such as central serous chorioretinopathy, nevus, pregnancy, or haemangiomas.
- Patients with diabetes mellitus.
- Patients with optical media opacity that significantly disturb optical coherence tomography image acquisition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Choroidal Thickness and Myopia Using Swept Source OCT
Optical coherence tomography is a non-invasive and non-contact imaging modality that enables two-dimensional cross-sectional and three-dimensional volumetric imaging of tissue architecture.
Read the detailed description
It has evolved over the past decade as one of the most important ancillary tests in ophthalmic practice. It is a noninvasive imaging technique and provides high resolution, cross-sectional images of the retina, the retinal nerve fiber layer and the optic nerve head. With axial resolution in the 5-7 μm range, it provides close to an in-vivo 'optical biopsy' of the retina. Optical coherence tomography employs light from a broadband light source, which is divided into a reference and a sample beam, to obtain a reflectivity versus depth profile of the retina. The light waves that are back scattered from the retina, interfere with the reference beam, and this interference pattern is used to measure the light echoes versus the depth profile of the tissue in vivo.
Recently, a new type of optical coherence tomography instrument, called a swept source optical coherence tomography, was introduced. The Swept source optical coherence tomography uses a tunable laser (swept-source) as a light source with a longer wavelength that allows the light to penetrate deeper into tissues than the conventional spectral domain optical coherence tomography instruments. This, then, enabled the imaging of the choroid.
Because choroidal abnormalities such as vascular hyperpermeability, vascular changes, loss and thinning are critical to the onset and progression of many ocular diseases, ophthalmologists and researchers are shifting their interest to the choroidal abnormalities.
Being a major vascular layer of the eye , choroid plays an important role in ocular health, and is involved in the pathogenesis of many intraocular diseases such as age-related macular degeneration , polypoidal choroidal vasculopathy , central serous chorioretinopathy and myopic macular degeneration. Accurate measurement of choroidal thickness in vivo is an essential step in monitoring disease onset and progression that lead to choroidal thinning. Based on histologic study, choroidal thickness ranges from 170 to 220 um.
These disorders show the need for understanding the choroidal structure in ocular diseases and the importance of having database of choroidal thickness.
- Conditions
- ESRD
- Being tested
- Swept source optical coherence tomography
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swept source optical coherence tomographyDevice
Measurement of choroidal thickness in myopic patients
| Study group | Role | What they receive |
|---|---|---|
| Study group | 97 eye of 49 normal Egyptian volunteers were divided into groups according to age, AL, SE of refractive error, minimum corneal thickness (MCT) and mean corneal power as follow:
Age into 3 groups:
Group A: from 18 to 30 years old Group B: from 31 to 40 years old Group C: > 40 years old
Axial length into 3 groups:
Group A: from 22 to less than 24 mm Group B: from 24 to 26 mm Group C: > 26 mm
Spherical equivalent of refractive error into :
Group A : from zero to - 2 D Group B : from - 2 to > - 4 D Group C : from - 4 to > - 6 D Group D: from - 6 to - 8 D
Minimum corneal thickness (MCT) into 3 groups:
Group i: < 500 um Group ii: from 500 to 540 um Group iii: > 540 um
Refractive power of cornea (Mean K) into 3 groups:
Group 1: 41 to less than 44 D Group 2: 44 to 46 D Group 3: > 46 D Receives: Device: Swept source optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between choroidal thickness and myopia
Analysis of choroidal thickness measured by swept source optical coherence tomography and the degree of myopia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start20 Mar 2017
- Primary completion1 Sep 2017
- Study completion31 Mar 2018
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 ESRDStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Rifaat Mokhtar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542448
- Sponsor's protocol ID
- ESSO
- Status last verified
- Nov 2018
- First submitted
- 18 May 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sull AC, Vuong LN, Price LL, Srinivasan VJ, Gorczynska I, Fujimoto JG, Schuman JS, Duker JS. Comparison of spectral/Fourier domain optical coherence tomography instruments for assessment of normal macular thickness. Retina. 2010 Feb;30(2):235-45. doi: 10.1097/IAE.0b013e3181bd2c3b.
PubMed 19952997
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Choroidal Thickness and Myopia Using Swept Source OCT
- ClinicalTrials.gov ID
- NCT03542448
- Acronym / sponsor ID
- ESSO
- Conditions
- ESRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 31 May 2018 (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.
Optical coherence tomography is a non-invasive and non-contact imaging modality that enables two-dimensional cross-sectional and three-dimensional volumetric imaging of tissue architecture.
Detailed description
It has evolved over the past decade as one of the most important ancillary tests in ophthalmic practice. It is a noninvasive imaging technique and provides high resolution, cross-sectional images of the retina, the retinal nerve fiber layer and the optic nerve head. With axial resolution in the 5-7 μm range, it provides close to an in-vivo 'optical biopsy' of the retina. Optical coherence tomography employs light from a broadband light source, which is divided into a reference and a sample beam, to obtain a reflectivity versus depth profile of the retina. The light waves that are back scattered from the retina, interfere with the reference beam, and this interference pattern is used to measure the light echoes versus the depth profile of the tissue in vivo.
Recently, a new type of optical coherence tomography instrument, called a swept source optical coherence tomography, was introduced. The Swept source optical coherence tomography uses a tunable laser (swept-source) as a light source with a longer wavelength that allows the light to penetrate deeper into tissues than the conventional spectral domain optical coherence tomography instruments. This, then, enabled the imaging of the choroid.
Because choroidal abnormalities such as vascular hyperpermeability, vascular changes, loss and thinning are critical to the onset and progression of many ocular diseases, ophthalmologists and researchers are shifting their interest to the choroidal abnormalities.
Being a major vascular layer of the eye , choroid plays an important role in ocular health, and is involved in the pathogenesis of many intraocular diseases such as age-related macular degeneration , polypoidal choroidal vasculopathy , central serous chorioretinopathy and myopic macular degeneration. Accurate measurement of choroidal thickness in vivo is an essential step in monitoring disease onset and progression that lead to choroidal thinning. Based on histologic study, choroidal thickness ranges from 170 to 220 um.
These disorders show the need for understanding the choroidal structure in ocular diseases and the importance of having database of choroidal thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Swept source optical coherence tomography97 eye of 49 normal Egyptian volunteers were divided into groups according to age, AL, SE of refractive error, minimum corneal thickness (MCT) and mean corneal power as follow: Age into 3 groups: Group A: from 18 to 30 years old Group B: from 31 to 40 years old Group C: > 40 years old Axial length into 3 groups: Group A: from 22 to less than 24 mm Group B: from 24 to 26 mm Group C: > 26 mm Spherical equivalent of refractive error into : Group A : from zero to - 2 D Group B : from - 2 to > - 4 D Group C : from - 4 to > - 6 D Group D: from - 6 to - 8 D Minimum corneal thickness (MCT) into 3 groups: Group i: < 500 um Group ii: from 500 to 540 um Group iii: > 540 um Refractive power of cornea (Mean K) into 3 groups: Group 1: 41 to less than 44 D Group 2: 44 to 46 D Group 3: > 46 D |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 case of age from 18 to 40 years old of myopic refraction from zero to -8 diopter , minimum corneal thickness from 500 to 540 micrometer , refractive power of cornea more than 41 diopter and axial length from 22 to 26 millimeter
Key inclusion criteria (5 listed)
- Age from 18 years to 40 age.
- Spherical equivalent from zero to -8.
- Minimum corneal thickness from 500 to 540.
- Refractive power of cornea more than 41 diopter.
- Axial length from 22 to 26.
Key exclusion criteria (8 listed)
- Corneal abnormalities such as ectasia.
- Eyes with dystrophic or degenerative diseases.
- Prior ocular surgery.
- Anterior or posterior segment inflammation.
- Glaucoma.
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 |
|---|---|---|
| Swept source optical coherence tomographyMeasurement of choroidal thickness in myopic patients | Device | Study group |
Primary outcome
Comparison between choroidal thickness and myopia
Time frame: Baseline
Analysis of choroidal thickness measured by swept source optical coherence tomography and the degree of myopia
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 28 Nov 2018.
- Background: PubMed 19952997Sull AC, Vuong LN, Price LL, Srinivasan VJ, Gorczynska I, Fujimoto JG, Schuman JS, Duker JS. Comparison of spectral/Fourier domain optical coherence tomography instruments for assessment of normal macular thickness. Retina. 2010 Feb;30(2):235-45. doi: 10.1097/IAE.0b013e3181bd2c3b.
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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 ESRD, 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 5 inclusion and 8 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 28 Nov 2018. 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?
Comparison between choroidal thickness and myopia (time frame: Baseline). 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 NCT03542448, 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 28 Nov 2018; AzTrials last refreshed its copy on 30 Oct 2026.