Eye DiseasesNCT04497207
Deep Learning for Classification of Scheimpflug Corneal Tomography Images
An observational study of Eye Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Scheimpflug Camera Corneal Tomography
- How many people
- 1,669 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2020to 25 Aug 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with keratoconus, subclinical keratoconus \& normal individuals from refractive surgery candidates.
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 diopteric (D) values >47.0D
- inferior- superior(I-S) asymmetry measured to be > 1.4 D
Show all 14Show fewer
- 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: Classification of Color-Coded Scheimpflug Camera Corneal Tomography Images Using Deep Learning
Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by Scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.
- Conditions
- Eye Diseases
- Being tested
- Scheimpflug Camera Corneal Tomography
- Keywords
- Keratoconus, Deep learning, Scheimpflug camera, Corneal tomography
- Medical subject headings
- Eye Diseases, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheimpflug Camera Corneal TomographyOther
Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir 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: Other: 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: Other: 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: Other: Scheimpflug Camera Corneal Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start10 Aug 2020
- Primary completion20 Aug 2020
- Study completion25 Aug 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,669 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
- NCT04497207
- Sponsor's protocol ID
- 17300437
- Status last verified
- Oct 2020
- First submitted
- 30 Jul 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Color-Coded Scheimpflug Camera Corneal Tomography Images Using Deep Learning
- ClinicalTrials.gov ID
- NCT04497207
- Acronym / sponsor ID
- 17300437
- Conditions
- Eye Diseases
- Keywords
- Keratoconus, Deep learning, Scheimpflug camera, Corneal tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,669 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 4 Aug 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.
Keratoconus is a common disorder. An early diagnosis influences the disease prognosis in the affected patients and prevents postoperative complications in patients with keratoconus considering refractive surgery. Machine learning approaches have been widely used for image classification. Here, we will assess the ability of deep learning to enable high-performance image classification of the color-coded corneal maps obtained by Scheimpflug camera in patients with keratoconus, subclinical keratoconus, and normal individuals.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Keratoconus | – | Other: 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 | – | Other: 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 | – | Other: 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 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with keratoconus, subclinical keratoconus \& normal individuals from refractive surgery candidates.
Key inclusion criteria (14 listed)
- 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 diopteric (D) values >47.0D
- inferior- superior(I-S) asymmetry measured to be > 1.4 D
Key exclusion criteria (4 listed)
- Systemic disease
- Other corneal disease such as pellucid marginal degeneration
- History of trauma
- Corneal surgery such as corneal cross- linking for progressive keratoconus.
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 anterir and posterior surfaces of the cornea to obtain corneal tomographic maps. | Other | Keratoconus, Normal, Subclinical keratoconus |
Primary outcome
Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels
Time frame: 2 days
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 6 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 6 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?
Croppedm denoised, and resized to obtain four separate image stacks of 256×256 pixels (time frame: 2 days). 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 6 Oct 2020.