NCT04251143

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2018Dec 2030

Study Start

First participant enrolled

March 12, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

7.8 years

First QC Date

January 30, 2020

Last Update Submit

February 27, 2023

Conditions

Corneal EctasiaCorneal DiseaseCorneal AstigmatismKeratoconusKeratopathy

Keywords

CorneaEctasiaKeratoconusCross-LinkingKeratoplasty

Outcome Measures

Primary Outcomes (2)

  • Follow-up intervals

    To find the best follow-up intervals for keratoconus patients with or without progression of the disease

    15 years

  • postoperative follow-up intervals

    To find the best follow-up intervals for keratoconus patients after surgical Intervention.

    15 years

Secondary Outcomes (1)

  • Assessment of treatment quality

    15 years

Study Arms (1)

Ectasia

Keratoconus, Keratoconus suspects

Procedure: corneal cross-linkingDiagnostic Test: corneal topography and tomography

Interventions

corneal cross-linkingPROCEDURE

UV-A Irradiation and riboflavin

Ectasia
corneal topography and tomographyDIAGNOSTIC_TEST

Detailed Information about corneal tomography is used for diagnosis

Ectasia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with corneal diseases attending a University Hospital Corneal Diseases Service.

You may qualify if:

  • corneal disease
  • corneal ectasia

You may not qualify if:

  • pregnancy
  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35606839DERIVED

  • 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.

    PMID: 34059127DERIVED

MeSH Terms

Conditions

Corneal DiseasesAstigmatismKeratoconusDilatation, Pathologic

Interventions

Corneal Cross-LinkingCorneal TopographyTomography

Condition Hierarchy (Ancestors)

Eye DiseasesRefractive ErrorsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhotochemotherapyCombined Modality TherapyTherapeuticsDrug TherapyPhototherapyDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisDiagnostic Imaging

Study Officials

  • Frederik Raiskup, MD, PhD

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

    STUDY DIRECTOR

Central Study Contacts

Robert Herber, MSc

CONTACT

004935145815091robert.herber@uniklinikum-dresden.de

Janine Lenk, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

January 31, 2020

Study Start

March 12, 2018

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2030

Last Updated

February 28, 2023

Record last verified: 2023-02

Locations

DE(1)