Clinical trial NCT04251143: Dresden Corneal Disease and Treatment 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Ectasia
Corneal Disease
Corneal Astigmatism
Keratoconus
Keratopathy
Keywords: Cornea
Ectasia
Keratoconus
Cross-Linking
Keratoplasty
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with corneal diseases attending a University Hospital Corneal Diseases Service.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* corneal disease
* corneal ectasia

Exclusion Criteria:

* pregnancy
* age under 18 years

Primary outcomes:
measure: Follow-up intervals
timeFrame: 15 years
measure: postoperative follow-up intervals
timeFrame: 15 years
Secondary outcomes:
measure: Assessment of treatment quality
timeFrame: 15 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden
state: Saxony
Study officials:
affiliation: Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden
name: Frederik Raiskup, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Herber 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.