Eye DiseasesNCT04582253
Pix2pix Networks for Scheimpflug Corneal Tomography Image Generation
An observational study of Eye Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Computer-aided medical image analysis has advantages, but requires large amounts of training data, which are scarce and costly to obtain, are subject to privacy concerns, and are often highly imbalanced, with over-representation of common conditions and poor representation of rare conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Scheimpflug Camera Corneal Tomography
- How many people
- 923 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Oct 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
- Healthy volunteers accepted
- Adult
Study population: Refractive surgery candidates with unilateral, bilateral, or forme fruste keratoconus, obtained between July 2014 and March 2019 at private eye center, Assiut, Egypt.
Who may be able to join
- Keratoconus group:
- Presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.
- irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues :
- focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones
- focal areas with dioptric (D) values >47.0D
- inferior- superior(I-S) asymmetry measured to be > 1.4 D
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- Angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis(SRAX) .
- Suspicious group:
- Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).
- Normal group:
- Refractive surgery candidates
- Refractive error of less than 8.0 D sphere
- Less than 3.0 D of astigmatism
- without clinical, topographic or tomographic signs of keratoconus or suspect keratoconus.
Who cannot join
- • Systemic disease
- Other corneal disease such as pellucid marginal degeneration
- History of trauma
- Corneal surgery such as corneal cross- linking for progressive keratoconus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pix2pix Conditional Generative Adversarial Networks for Scheimpflug Camera Color-coded Corneal Tomography Image Generation
Computer-aided medical image analysis has advantages, but requires large amounts of training data, which are scarce and costly to obtain, are subject to privacy concerns, and are often highly imbalanced, with over-representation of common conditions and poor representation of rare conditions. Consequently, some methods have been proposed to generate artificial medical images using generative adversarial networks (GANs). Computer aided diagnosis of keratoconus is an emerging research field that may benefit greatly from medical image synthesis, which can affordably provide an arbitrary number of sufficiently diverse synthetic images that mimic real Pentacam images. A new conditional GAN, the pix2pix cGAN, has not been used in this context to date. Here, investigators will assess the efficacy of a cGAN implementing pix2pix image translation for image synthesis of color-coded Pentacam 4-map refractive displays of clinical and subclinical keratoconus as well as normal corneas.
- Conditions
- Eye Diseases
- Being tested
- Scheimpflug Camera Corneal Tomography
- Keywords
- Cornea, Imaging
- Medical subject headings
- Eye Diseases, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheimpflug Camera Corneal TomographyDiagnostic test
Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterior and posterior surfaces of the cornea to obtain corneal tomographic maps.
| Study group | Role | What they receive |
|---|---|---|
| Keratoconus | Those with a clinical diagnosis of keratoconus such as:
a) the presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.(b) an irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues: focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones, focal areas with dioptric (D) values >47.0D, inferior- superior(I-S) asymmetry measured to be > 1.4 D or angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis (SRAX) 2. Receives: Diagnostic Test: Scheimpflug Camera Corneal Tomography | |
| Subclinical keratoconus | Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (subclinical keratoconus). Receives: Diagnostic Test: Scheimpflug Camera Corneal Tomography | |
| Normal | This group comprised refractive surgery candidates and subjects applying for a contact lens fitting with a refractive error of less than 8.0 D sphere with less than 3.0 D of astigmatism and without clinical, topographic or tomographic signs of keratoconus nor suspected keratoconus. Receives: Diagnostic Test: Scheimpflug Camera Corneal Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN)
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 posted9 Oct 2020
- Study start1 Aug 2020
- Primary completion20 Aug 2020
- Study completion1 Oct 2020
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 923 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
- NCT04582253
- Sponsor's protocol ID
- 17300483
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 19 Oct 2020
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pix2pix Conditional Generative Adversarial Networks for Scheimpflug Camera Color-coded Corneal Tomography Image Generation
- ClinicalTrials.gov ID
- NCT04582253
- Acronym / sponsor ID
- 17300483
- Conditions
- Eye Diseases
- Keywords
- Cornea, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 923 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Oct 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.
Computer-aided medical image analysis has advantages, but requires large amounts of training data, which are scarce and costly to obtain, are subject to privacy concerns, and are often highly imbalanced, with over-representation of common conditions and poor representation of rare conditions. Consequently, some methods have been proposed to generate artificial medical images using generative adversarial networks (GANs). Computer aided diagnosis of keratoconus is an emerging research field that may benefit greatly from medical image synthesis, which can affordably provide an arbitrary number of sufficiently diverse synthetic images that mimic real Pentacam images. A new conditional GAN, the pix2pix cGAN, has not been used in this context to date. Here, investigators will assess the efficacy of a cGAN implementing pix2pix image translation for image synthesis of color-coded Pentacam 4-map refractive displays of clinical and subclinical keratoconus as well as normal corneas.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Keratoconus | – | Diagnostic Test: Scheimpflug Camera Corneal TomographyThose with a clinical diagnosis of keratoconus such as: a) the presence of a central protrusion of the cornea with Fleischer ring, Vogt striae, or both by slitlamp examination.(b) an irregular cornea determined by distorted keratometry mires and distortion of retinoscopic red reflex or both in addition to the following topographic findings as summarized by Pińero and colleagues: focal steepening located in a zone of protrusion surrounded by concentrically decreasing power zones, focal areas with dioptric (D) values >47.0D, inferior- superior(I-S) asymmetry measured to be > 1.4 D or angling of the hemimeridians in an asymmetric or broken bowtie pattern with skewing of the steepest radial axis (SRAX) 2. |
| Subclinical keratoconus | – | Diagnostic Test: Scheimpflug Camera Corneal TomographyDefined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (subclinical keratoconus). |
| Normal | – | Diagnostic Test: Scheimpflug Camera Corneal TomographyThis group comprised refractive surgery candidates and subjects applying for a contact lens fitting with a refractive error of less than 8.0 D sphere with less than 3.0 D of astigmatism and without clinical, topographic or tomographic signs of keratoconus nor suspected keratoconus. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Refractive surgery candidates with unilateral, bilateral, or forme fruste keratoconus, obtained between July 2014 and March 2019 at private eye center, Assiut, Egypt.
Key inclusion criteria (14 listed)
- Keratoconus group:
- Defined as subtle corneal tomographic changes as the aforementioned keratoconus abnormalities in the absence of slit- lamp or visual acuity changes typical of keratoconus (forme fruste keratoconus).
- Refractive surgery candidates
- Refractive error of less than 8.0 D sphere
- Less than 3.0 D of astigmatism
Key exclusion criteria (4 listed)
- • Systemic disease
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 |
|---|---|---|
| Scheimpflug Camera Corneal TomographyPentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterior and posterior surfaces of the cornea to obtain corneal tomographic maps. | Diagnostic test | Keratoconus, Normal, Subclinical keratoconus |
Primary outcome
Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN)
Time frame: 1 day
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 19 Oct 2020.
- 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 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 14 inclusion and 4 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 19 Oct 2020. 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?
Scheimpflug camera color-coded corneal tomography images created by pix2pix conditional adversarial network (pix2pix cGAN) (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 19 Oct 2020.