Corneal EctasiaNCT04251143
Dresden Corneal Disease and Treatment Study
An observational study of Corneal Ectasia and Corneal Disease, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism
- What is being tested?
- corneal cross-linking and corneal topography and tomography
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteGermany
- Study dates
- 12 Mar 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with corneal diseases attending a University Hospital Corneal Diseases Service.
Who may be able to join
- corneal disease
- corneal ectasia
Who cannot join
- pregnancy
- age under 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janine Lenk, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden
Dresden, Saxony, 01307
Robert Herber, 004935145815091, robert.herber@uniklinikum-dresden.de
Janine Lenk, MD
About this study
Official title: Dresden Corneal Disease and Treatment Study - Analysis for Quality Inspection of Follow-up and Treatment Procedures of Corneal Diseases of the Department of Ophthalmology (University Hospital Carl Gustav Carus Dresden)
The purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. Overall, a long-term follow up is needed to evaluate an early disease progression as well as corneal stability after surgical intervention.
Read the detailed description
Corneal ectasia (e.g. keratoconus) is a corneal disease that is characterized by irregular steepening of corneal curvature, stromal thinning and reduced biomechanical properties. As a result of this, visual acuity is reduced and can improved by spectacles in early state or with rigid gas permeable contact lenses in mild as well as advanced stage of the disease. Furthermore, in moderate and advanced cases stromal scarring occurs that affected the vision negatively. Therefore, a corneal transplantation is needed. Since the introduction of corneal cross-linking, the amount of corneal transplantations has been reduced. It is necessary to perform closely examinations to detect the progression of the disease as well as post-operatively follow-ups to confirm treatment success.
Parameters being analyzed are:
Age, sex, refraction, family history, known duration of ectasia, previous ocular surgery, systemic diseases, systemic and topical medication;
biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.
- Conditions
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus, Keratopathy
- Being tested
- corneal cross-linking, corneal topography and tomography
- Keywords
- Cornea, Ectasia, Keratoconus, Cross-Linking, Keratoplasty
- Medical subject headings
- Corneal Diseases, Astigmatism, Keratoconus, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal cross-linkingProcedure or surgery
UV-A Irradiation and riboflavin
corneal topography and tomographyDiagnostic test
Detailed Information about corneal tomography is used for diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Ectasia | Keratoconus, Keratoconus suspects Receives: Procedure: corneal cross-linking; Diagnostic Test: corneal topography and tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up intervals
To find the best follow-up intervals for keratoconus patients with or without progression of the disease
Measured: 15 years
postoperative follow-up intervals
To find the best follow-up intervals for keratoconus patients after surgical Intervention.
Measured: 15 years
Secondary outcomes (1)
Assessment of treatment quality
What is the best treatment option for the individual patient?
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start12 Mar 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederik Raiskup, MD, PhD, Study director, Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251143
- Sponsor's protocol ID
- EK 104032018
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2020
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Herber R, Lenk J, Pillunat LE, Raiskup F. Comparison of corneal tomography using a novel swept-source optical coherence tomographer and rotating Scheimpflug system in normal and keratoconus eyes: repeatability and agreement analysis. Eye Vis (Lond). 2022 May 23;9(1):19. doi: 10.1186/s40662-022-00290-6.
PubMed 35606839Herber R, Pillunat LE, Raiskup F. Development of a classification system based on corneal biomechanical properties using artificial intelligence predicting keratoconus severity. Eye Vis (Lond). 2021 Jun 1;8(1):21. doi: 10.1186/s40662-021-00244-4.
PubMed 34059127
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dresden Corneal Disease and Treatment Study - Analysis for Quality Inspection of Follow-up and Treatment Procedures of Corneal Diseases of the Department of Ophthalmology (University Hospital Carl Gustav Carus Dresden)
- ClinicalTrials.gov ID
- NCT04251143
- Acronym / sponsor ID
- EK 104032018
- Conditions
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus, Keratopathy
- Keywords
- Cornea, Ectasia, Keratoconus, Cross-Linking, Keratoplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 31 Jan 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.
The purpose of this study is long-term follow up of patients with corneal diseases to analyze the quality of surgical interventions and diagnosis. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. Overall, a long-term follow up is needed to evaluate an early disease progression as well as corneal stability after surgical intervention.
Detailed description
Corneal ectasia (e.g. keratoconus) is a corneal disease that is characterized by irregular steepening of corneal curvature, stromal thinning and reduced biomechanical properties. As a result of this, visual acuity is reduced and can improved by spectacles in early state or with rigid gas permeable contact lenses in mild as well as advanced stage of the disease. Furthermore, in moderate and advanced cases stromal scarring occurs that affected the vision negatively. Therefore, a corneal transplantation is needed. Since the introduction of corneal cross-linking, the amount of corneal transplantations has been reduced. It is necessary to perform closely examinations to detect the progression of the disease as well as post-operatively follow-ups to confirm treatment success.
Parameters being analyzed are:
Age, sex, refraction, family history, known duration of ectasia, previous ocular surgery, systemic diseases, systemic and topical medication;
biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectasia | – | Procedure: corneal cross-linking, Diagnostic Test: corneal topography and tomographyKeratoconus, Keratoconus suspects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with corneal diseases attending a University Hospital Corneal Diseases Service.
Key inclusion criteria (2 listed)
- corneal disease
- corneal ectasia
Key exclusion criteria (2 listed)
- pregnancy
- age under 18 years
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 |
|---|---|---|
| corneal cross-linkingUV-A Irradiation and riboflavin | Procedure or surgery | Ectasia |
| corneal topography and tomographyDetailed Information about corneal tomography is used for diagnosis | Diagnostic test | Ectasia |
Primary outcome
Follow-up intervals
Time frame: 15 years
To find the best follow-up intervals for keratoconus patients with or without progression of the disease
postoperative follow-up intervals
Time frame: 15 years
To find the best follow-up intervals for keratoconus patients after surgical Intervention.
1 secondary outcome
Assessment of treatment quality
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 35606839Herber R, Lenk J, Pillunat LE, Raiskup F. Comparison of corneal tomography using a novel swept-source optical coherence tomographer and rotating Scheimpflug system in normal and keratoconus eyes: repeatability and agreement analysis. Eye Vis (Lond). 2022 May 23;9(1):19. doi: 10.1186/s40662-022-00290-6.
- Derived from this study: PubMed 34059127Herber R, Pillunat LE, Raiskup F. Development of a classification system based on corneal biomechanical properties using artificial intelligence predicting keratoconus severity. Eye Vis (Lond). 2021 Jun 1;8(1):21. doi: 10.1186/s40662-021-00244-4.
Related trials for Corneal Ectasia
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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.
Janine Lenk, MD contact
Frederik Raiskup, MD, PhD study director
Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden
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 Corneal Ectasia and Corneal Disease, run by Technische Universität Dresden at 1 site in Germany.
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 2 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: looking for participants now, as of the sponsor's last update on 28 Feb 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Herber, MSc (004935145815091, robert.herber@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up intervals (time frame: 15 years). The study lists 2 primary outcomes in all. 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 NCT04251143, which also lists 2 linked publications.
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 Feb 2023.