KeratoconusNCT02428166
Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
An observational study of Keratoconus, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Keratoconus
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months
Who may be able to join
- Keratoconus patients after unilateral crosslinking treatment
Who cannot join
- Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)
- Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of ophthalmology, University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.
- Conditions
- Keratoconus
- Keywords
- crosslinking, keratoconus, keratometry, pachymetry, pentacam
- Medical subject headings
- Keratoconus
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum keratometry (Kmax) as measured by the Pentacam HR
Measured: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative
Secondary outcomes (3)
Change in corneal thickness as measured by the Pentacam HR
Measured: retrospective analysis from preoperatively to 2-14 months postoperatively
Change in visual acuity (VA)
Measured: retrospective analysis from preoperatively to 2-14 months postoperatively
Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome
Measured: retrospective analysis from preoperatively to 2-14 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Mike P. Holzer, Heidelberg University
- Investigators
- Mike P Holzer, MD, FEBO, Principal investigator, Department of ophthalmology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428166
- Sponsor's protocol ID
- S-004/2015
- Status last verified
- Dec 2017
- First submitted
- 23 Apr 2015
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye
- ClinicalTrials.gov ID
- NCT02428166
- Acronym / sponsor ID
- S-004/2015
- Conditions
- Keratoconus
- Keywords
- crosslinking, keratoconus, keratometry, pachymetry, pentacam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- 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 retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Eligible keratoconus patients aged 18-50 years who underwent unilateral crosslinking treatment in our ophthalmology department and completed a postoperative follow-up of 2-14 months
Key inclusion criteria (1 listed)
- Keratoconus patients after unilateral crosslinking treatment
Key exclusion criteria (2 listed)
- Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)
- Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in maximum keratometry (Kmax) as measured by the Pentacam HR
Time frame: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative
3 secondary outcomes
Change in corneal thickness as measured by the Pentacam HR
Time frame: retrospective analysis from preoperatively to 2-14 months postoperatively
Change in visual acuity (VA)
Time frame: retrospective analysis from preoperatively to 2-14 months postoperatively
Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome
Time frame: retrospective analysis from preoperatively to 2-14 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
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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. This study is not recruiting at the moment.
Mike P Holzer, MD, FEBO principal investigator
Department of ophthalmology, University of Heidelberg
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 Keratoconus, run by Heidelberg University 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 1 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: finished, as of the sponsor's last update on 13 Dec 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum keratometry (Kmax) as measured by the Pentacam HR (time frame: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2017.