Endothelial DystrophyNCT01682421
Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation
A study testing Weak steroid (Flurolon, Allergan) and Potent steroid (Maxidex, Alcon) in people with Endothelial Dystrophy and Secondary Bullous Keratopathy, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection. However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dystrophy, Secondary Bullous Keratopathy, Posterior Lamellar Keratoplasty
- What is being tested?
- Weak steroid (Flurolon, Allergan) and Potent steroid (Maxidex, Alcon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Sep 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital
Who cannot join
- Not fulfilling the above
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Ophthalmology, Aarhus Universtity Hospital
Aarhus, DK-8000
About this study
Official title: Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation
After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.
However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.
Read more
Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.
The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.
- Conditions
- Endothelial Dystrophy, Secondary Bullous Keratopathy, Posterior Lamellar Keratoplasty, Descemet's Stripping Endothelial Keratoplasty
- Being tested
- Weak steroid (Flurolon, Allergan), Potent steroid (Maxidex, Alcon)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weak steroid (Flurolon, Allergan)Drug
Also called Flurolon, Allergan
Potent steroid (Maxidex, Alcon)Drug
Also called Maxidex, Alcon
| Study group | Role | What they receive |
|---|---|---|
| Weak steroid | Experimental | Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years. Receives: Drug: Weak steroid (Flurolon, Allergan) |
| Potent steroid | Experimental | Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment. Receives: Drug: Potent steroid (Maxidex, Alcon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from rejection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DystrophyStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Ivarsen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682421
- Sponsor's protocol ID
- AUH_DSAEK_STEROID
- Status last verified
- Oct 2026
- First submitted
- 4 Sep 2012
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation
- ClinicalTrials.gov ID
- NCT01682421
- Acronym / sponsor ID
- AUH_DSAEK_STEROID
- Conditions
- Endothelial Dystrophy, Secondary Bullous Keratopathy, Posterior Lamellar Keratoplasty, Descemet's Stripping Endothelial Keratoplasty
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Sep 2012 (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.
After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.
However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.
Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.
The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weak steroid | Experimental | Drug: Weak steroid (Flurolon, Allergan)Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years. |
| Potent steroid | Experimental | Drug: Potent steroid (Maxidex, Alcon)Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital
Key exclusion criteria (1 listed)
- Not fulfilling the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weak steroid (Flurolon, Allergan)Also: Flurolon, Allergan | Drug | Weak steroid |
| Potent steroid (Maxidex, Alcon)Also: Maxidex, Alcon | Drug | Potent steroid |
Primary outcome
Freedom from rejection
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weak steroid (Flurolon, Allergan) and Potent steroid (Maxidex, Alcon) in people with Endothelial Dystrophy and Secondary Bullous Keratopathy, run by Aarhus University Hospital at 1 site in Denmark.
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 1 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: withdrawn, as of the sponsor's last update on 28 Oct 2026. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Freedom from rejection (time frame: 2 years). 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 28 Oct 2026.