Map Dot Fingerprint DystrophyNCT05770492
Deep Learning Assisted Epithelial Basement Membrane Dystrophy Detection
An observational study of Map Dot Fingerprint Dystrophy, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Epithelial basement membrane dystrophy, also known as Map-Dot fingerprint dystrophy or Cogan microcystic dystrophy, is a common bilateral dystrophy of the anterior human cornea. According to one study, it affects approximately 2% of the human population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Map Dot Fingerprint Dystrophy
- What is being tested?
- anterior segment optical coherence tomography
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 27 Feb 2023to 27 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Age 18 or older
- Written informed consent
- Presence of epithelial basement membrane dystrophy
- Age 18 or older
- Written informed consent
- No corneal pathology in both eyes
Who cannot join
- Other corneal conditions (such as corneal scarring, fuchs endothelial corneal dystrophy, etc.)
- Pregnancy (pregnancy test will be taken in women of reproductive age), nursing women
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Andreas Schlatter, MD, +43 1 91021- 57564, a.schlatter@viros.at
About this study
Official title: Automated Deep Learning for Detection of Epithelial Basement Membrane Dystrophy Using Optical Coherence Tomography and Longitudinal Reproducibility of Disease Characteristics
Epithelial basement membrane dystrophy, also known as Map-Dot fingerprint dystrophy or Cogan microcystic dystrophy, is a common bilateral dystrophy of the anterior human cornea. According to one study, it affects approximately 2% of the human population. A more recent study even reported basement membrane changes in 25% of the general population. However, due to its clinical and morphological appearance, the disease is probably often overlooked.
Although epithelial basement membrane dystrophy is asymptomatic in many affected patients, there are some important clinical consequences of the disease to consider: Dystrophy is estimated to be the second most common cause of recurrent corneal erosion syndrome and is also an important differential diagnosis of dry eye disease. Therefore, it can cause severe pain in affected patients. In addition, epithelial basement membrane dystrophy plays an important role in the context of cataract surgery, one of the most commonly performed surgeries worldwide: besides the importance of appropriate disease management before surgery to prevent postoperative exacerbation of ocular surface symptoms, epithelial basement membrane dystrophy is also a risk factor for inaccurate preoperative biometry.
Read more
In recent years, specific features of epithelial basement membrane dystrophy have been introduced in examination methods other than slit-lamp biomicroscopy, such as epithelial thickness mapping or optical coherence tomography. Due to the recent introduction of a variety of deep learning systems, the application of machine learning could significantly increase the detection rate for epithelial basement membrane dystrophy. Furthermore, to the best of our knowledge, the change in disease characteristics over time is currently unknown.
Therefore, the first part of this study will investigate the ability of an automated deep learning system using optical coherence tomography scans to distinguish between normal human corneas and corneas affected by epithelial basement membrane dystrophy. For this purpose, 100 eyes of 50 patients will be included in both study groups. In an optional 2nd part of the study, a second visit will be planned in patients with epithelial basement membrane dystrophy to investigate the reproducibility of disease characteristics as a secondary outcome.
Read the detailed description
This study aims to investigate the capability of an automated deep learning system using anterior segment optical coherence tomography scans to distinguish between normal human corneas and corneas affected by epithelial basement membrane dystrophy. In an optional substudy, a second visit will be scheduled to investigate the reproducibility of disease characteristics as a secondary outcome.
One-hundred eyes of 50 patients with epithelial basement membrane dystrophy and 100 eyes of 50 healthy subjects will be included in this study. After successful screening, all study participants will undergo one single study visit. During this visit, two questionnaires (Ocular Surface Disease Index, Quality of Vision), two different anterior segment optical coherence tomography devices (MS-39, Anterion), a slit lamp examination including slit lamp photography will be performed.
In an optional substudy, patients with epithelial basement membrane dystrophy will have a second visit, to compare the variability of disease characteristics, including number of maps, dots, fingerprint lines and cysts between the two visits.
- Conditions
- Map Dot Fingerprint Dystrophy
- Being tested
- anterior segment optical coherence tomography
- Medical subject headings
- Corneal dystrophy, epithelial basement membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior segment optical coherence tomographyDiagnostic test
Two different optical systems (MS-39, Costruzione Strumenti Oftalmici Italy; Anterion optical coherence tomographer, Heidelberg Engineering) will be used for acquisition of cross-sectional scans. Radial scan patterns will be used for acquisition.
| Study group | Role | What they receive |
|---|---|---|
| Epithelial Basement Membrane Dystrophy | Patients with epithelial basement membrane dystrophy Receives: Diagnostic Test: anterior segment optical coherence tomography | |
| Healthy | Patients/Subjects without corneal pathologies Receives: Diagnostic Test: anterior segment optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the deep learning system to detect optical coherence tomography scans with epithelial basement membrane dystrophy on the final test data set
Measured: 1 day
Specificity of the deep learning system to detect optical coherence tomography scans with epithelial basement membrane dystrophy on the final test data set
Measured: 1 day
Area under the curve of the deep learning algorithm on the final test data set
Measured: 1 day
Secondary outcomes (12)
Interobserver variability regarding disease diagnosis (normal cornea vs. epithelial basement membrane dystrophy) according to slit lamp photographies
Measured: 1 day
Interobserver variability regarding number of maps according to slit lamp photographies
Measured: 1 day
Interobserver variability regarding number of dots according to slit lamp photographies
Measured: 1 day
Interobserver variability regarding number of fingerprints according to slit lamp photographies
Measured: 1 day
Interobserver variability regarding number of cysts according to slit lamp photographies
Measured: 1 day
Difference in epithelial thickness mapping between healthy corneas and corneas affected by epithelial basement membrane dystrophy
Measured: 1 day
Difference in Ocular Surface Disease Index between healthy subjects and patients affected by epithelial basement membrane dystrophy
minimum: 0, maximum: 100, higher scores are associated with increased symptoms regarding ocular surface disease
Measured: 1 day
Difference in Quality of Vision questionnaire score between healthy subjects and patients affected by epithelial basement membrane dystrophy
0- to 100-unit linear scale, higher scores indicating poorer quality of vision
Measured: 1 day
Sub-study only: Reproducibility of number of maps between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
number of corneal maps will be assessed by a clinical investigator at both visits
Measured: 3 months
Sub-study only: Reproducibility of number of dots between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
number of corneal dots will be assessed by a clinical investigator at both visits
Measured: 3 months
Sub-study only: Reproducibility of number of fingerprints between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
number of corneal fingerprint lines will be assessed by a clinical investigator at both visits
Measured: 3 months
Sub-study only: Reproducibility of number of cysts between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
number of corneal cysts will be assessed by a clinical investigator at both visits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start27 Feb 2023
- Primary completion27 Feb 2024 (estimated)
- Study completion27 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Map Dot Fingerprint DystrophyStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770492
- Sponsor's protocol ID
- DL_EBMD
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Deep Learning for Detection of Epithelial Basement Membrane Dystrophy Using Optical Coherence Tomography and Longitudinal Reproducibility of Disease Characteristics
- ClinicalTrials.gov ID
- NCT05770492
- Acronym / sponsor ID
- DL_EBMD
- Conditions
- Map Dot Fingerprint Dystrophy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 27 Feb 2024 (estimated)
- First posted
- 15 Mar 2023 (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.
Epithelial basement membrane dystrophy, also known as Map-Dot fingerprint dystrophy or Cogan microcystic dystrophy, is a common bilateral dystrophy of the anterior human cornea. According to one study, it affects approximately 2% of the human population. A more recent study even reported basement membrane changes in 25% of the general population. However, due to its clinical and morphological appearance, the disease is probably often overlooked.
Although epithelial basement membrane dystrophy is asymptomatic in many affected patients, there are some important clinical consequences of the disease to consider: Dystrophy is estimated to be the second most common cause of recurrent corneal erosion syndrome and is also an important differential diagnosis of dry eye disease. Therefore, it can cause severe pain in affected patients. In addition, epithelial basement membrane dystrophy plays an important role in the context of cataract surgery, one of the most commonly performed surgeries worldwide: besides the importance of appropriate disease management before surgery to prevent postoperative exacerbation of ocular surface symptoms, epithelial basement membrane dystrophy is also a risk factor for inaccurate preoperative biometry.
In recent years, specific features of epithelial basement membrane dystrophy have been introduced in examination methods other than slit-lamp biomicroscopy, such as epithelial thickness mapping or optical coherence tomography. Due to the recent introduction of a variety of deep learning systems, the application of machine learning could significantly increase the detection rate for epithelial basement membrane dystrophy. Furthermore, to the best of our knowledge, the change in disease characteristics over time is currently unknown.
Therefore, the first part of this study will investigate the ability of an automated deep learning system using optical coherence tomography scans to distinguish between normal human corneas and corneas affected by epithelial basement membrane dystrophy. For this purpose, 100 eyes of 50 patients will be included in both study groups. In an optional 2nd part of the study, a second visit will be planned in patients with epithelial basement membrane dystrophy to investigate the reproducibility of disease characteristics as a secondary outcome.
Detailed description
This study aims to investigate the capability of an automated deep learning system using anterior segment optical coherence tomography scans to distinguish between normal human corneas and corneas affected by epithelial basement membrane dystrophy. In an optional substudy, a second visit will be scheduled to investigate the reproducibility of disease characteristics as a secondary outcome.
One-hundred eyes of 50 patients with epithelial basement membrane dystrophy and 100 eyes of 50 healthy subjects will be included in this study. After successful screening, all study participants will undergo one single study visit. During this visit, two questionnaires (Ocular Surface Disease Index, Quality of Vision), two different anterior segment optical coherence tomography devices (MS-39, Anterion), a slit lamp examination including slit lamp photography will be performed.
In an optional substudy, patients with epithelial basement membrane dystrophy will have a second visit, to compare the variability of disease characteristics, including number of maps, dots, fingerprint lines and cysts between the two visits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epithelial Basement Membrane Dystrophy | – | Diagnostic Test: anterior segment optical coherence tomographyPatients with epithelial basement membrane dystrophy |
| Healthy | – | Diagnostic Test: anterior segment optical coherence tomographyPatients/Subjects without corneal pathologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- Age 18 or older
- Written informed consent
- Presence of epithelial basement membrane dystrophy
- Age 18 or older
- Written informed consent
Key exclusion criteria (2 listed)
- Other corneal conditions (such as corneal scarring, fuchs endothelial corneal dystrophy, etc.)
- Pregnancy (pregnancy test will be taken in women of reproductive age), nursing 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 |
|---|---|---|
| anterior segment optical coherence tomographyTwo different optical systems (MS-39, Costruzione Strumenti Oftalmici Italy; Anterion optical coherence tomographer, Heidelberg Engineering) will be used for acquisition of cross-sectional scans. Radial scan patterns will be used for acquisition. | Diagnostic test | Epithelial Basement Membrane Dystrophy, Healthy |
Primary outcome
Sensitivity of the deep learning system to detect optical coherence tomography scans with epithelial basement membrane dystrophy on the final test data set
Time frame: 1 day
Specificity of the deep learning system to detect optical coherence tomography scans with epithelial basement membrane dystrophy on the final test data set
Time frame: 1 day
Area under the curve of the deep learning algorithm on the final test data set
Time frame: 1 day
12 secondary outcomes
Interobserver variability regarding disease diagnosis (normal cornea vs. epithelial basement membrane dystrophy) according to slit lamp photographies
Time frame: 1 day
Interobserver variability regarding number of maps according to slit lamp photographies
Time frame: 1 day
Interobserver variability regarding number of dots according to slit lamp photographies
Time frame: 1 day
Interobserver variability regarding number of fingerprints according to slit lamp photographies
Time frame: 1 day
Interobserver variability regarding number of cysts according to slit lamp photographies
Time frame: 1 day
Difference in epithelial thickness mapping between healthy corneas and corneas affected by epithelial basement membrane dystrophy
Time frame: 1 day
Difference in Ocular Surface Disease Index between healthy subjects and patients affected by epithelial basement membrane dystrophy
Time frame: 1 day
Difference in Quality of Vision questionnaire score between healthy subjects and patients affected by epithelial basement membrane dystrophy
Time frame: 1 day
Sub-study only: Reproducibility of number of maps between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
Time frame: 3 months
Sub-study only: Reproducibility of number of dots between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
Time frame: 3 months
Sub-study only: Reproducibility of number of fingerprints between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
Time frame: 3 months
Sub-study only: Reproducibility of number of cysts between visit 1 and visit 2 according to slit lamp photographies and optical coherence tomography images
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Map Dot Fingerprint Dystrophy
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Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties
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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.
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 Map Dot Fingerprint Dystrophy, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, MD, MBA, FEBO (+43 1 91021- 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the deep learning system to detect optical coherence tomography scans with epithelial basement membrane dystrophy on the final test data set (time frame: 1 day). The study lists 3 primary outcomes in all. 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 15 Mar 2023.