Dresden Corneal Disease and Treatment Study

NCT ID: NCT04251143

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2030-12-31

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.

Conditions

Corneal Ectasia; Corneal Disease; Corneal Astigmatism; Keratoconus; Keratopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ectasia

Keratoconus, Keratoconus suspects

corneal cross-linking

Intervention Type: PROCEDURE

UV-A Irradiation and riboflavin

corneal topography and tomography

Intervention Type: DIAGNOSTIC_TEST

Detailed Information about corneal tomography is used for diagnosis

Interventions

corneal cross-linking

UV-A Irradiation and riboflavin

Intervention Type: PROCEDURE

corneal topography and tomography

Detailed Information about corneal tomography is used for diagnosis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• corneal disease
• corneal ectasia

Exclusion Criteria

• pregnancy
• age under 18 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederik Raiskup, MD, PhD

Role: STUDY_DIRECTOR

Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden

Locations

Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Robert Herber, MSc

Role: CONTACT

robert.herber@uniklinikum-dresden.de

004935145815091

Janine Lenk, MD

Role: CONTACT

Facility Contacts

Robert Herber

Role: primary

robert.herber@uniklinikum-dresden.de

004935145815091

References

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.

Reference Type: DERIVED

PMID: 35606839 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34059127 (View on PubMed)

Other Identifiers

EK 104032018

Identifier Type: -

Identifier Source: org_study_id