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RecruitingNCT04251143Updated Feb 28, 2023

Dresden Corneal Disease and Treatment Study

An observational study in Corneal Ectasia, Corneal Disease and Corneal Astigmatism, sponsored by Technische Universität Dresden. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-28.

Primary conditionKeratoconusRegistry: Corneal DiseasesReclassifiedWhy we changed it
Registry
Corneal Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Keratoconus
Why
  1. The study's listed conditions name Keratoconus, a narrower term within Corneal Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Technische Universität Dresden · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2018; still recruiting 8 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Corneal Ectasia
  • Corneal Disease
  • Corneal Astigmatism
  • Keratoconus
  • Keratopathy

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Keywords

  • Cornea
  • Ectasia
  • Keratoconus
  • Cross-Linking
  • Keratoplasty
03

In context

Keratoconus Reclassified

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 700 is above the median of 130 across 97 observational studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

Browse Technische Universität Dresden studies →

Compared within Keratoconus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Corneal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • corneal disease
  • corneal ectasia

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • age under 18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ectasia

    Keratoconus, Keratoconus suspects

    Procedure: corneal cross-linking · Diagnostic Test: corneal topography and tomography

Interventions

  • Procedurecorneal cross-linking

    UV-A Irradiation and riboflavin

  • Diagnostic testcorneal topography and tomography

    Detailed Information about corneal tomography is used for diagnosis

06

What researchers measure

Primary outcomes

  1. Follow-up intervals

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

    Time frame: 15 years

  2. postoperative follow-up intervals

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

    Time frame: 15 years

Secondary outcomes

  1. Assessment of treatment quality

    What is the best treatment option for the individual patient?

    Time frame: 15 years

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden
    Dresden, Saxony 01307, Germany
    Recruiting
08

References and documents

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 35606839 ↗
  • 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. PubMed 34059127 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Dec 2025, 93 months after the start.

Of 33 non-industry observational studies under Keratoconus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 204. This study's planned 93 months is above that.

Counting every sponsor, half of 36 studies reached it within 30 months; a quarter within 13 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2020
First posted
Jan 31, 2020
StartActual
Mar 12, 2018
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2030
Last update
Feb 28, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04251143
Lead sponsor
Technische Universität Dresden
Responsible party
Sponsor
First posted
Jan 31, 2020
Start date
Mar 12, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Feb 28, 2023

Study contacts

Robert Herber, MSc
Contact
robert.herber@uniklinikum-dresden.de
004935145815091
Janine Lenk, MD
Contact
Frederik Raiskup, MD, PhD
study director · Department of Ophthalmology; Medical Faculty Carl Gustav Carus, Techinal University Dresden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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