Corneal Dystrophies, HereditaryDSAEKNCT00543660
Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
A study testing Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) in people with Corneal Dystrophies, Hereditary, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.
Trial summary
To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Corneal Dystrophies, Hereditary
- What is being tested?
- Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 1998to Mar 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal endothelial disorders
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Institute for Innovative Ocular Surgery
Rotterdam, 3071 AA
About this study
To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
Read the detailed description
Please see above.
- Conditions
- Corneal Dystrophies, Hereditary
- Being tested
- Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
- Keywords
- Corneal transplantation, Descemet membrane, endothelium
- Medical subject headings
- Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Procedure or surgery
Also called Descemet Stripping Endothelial Keratoplasty (DSEK), Please see www.niios.com
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm DSEK | Experimental | Intervention: DSEK Receives: Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best spectacle corrected visual acuity
Measured: 1998 - 2018
Secondary outcomes (1)
Corneal endothelial cell density
Measured: 1998-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2007 (estimated)
- Study startMar 1998
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Dystrophies, HereditaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Innovative Ocular Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Amnitrans Eyebank Rotterdam, Melles CorneaClinic Rotterdam
- Responsible party
- Principal investigator, GRJ Melles, MD, PhD, Netherlands Institute for Innovative Ocular Surgery
- Investigators
- Gerrit RJ Melles, MD PhD, Principal investigator, Netherlands Institute for Innovative Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543660
- Sponsor's protocol ID
- NIIOS.1998.04
- Acronym
- DSAEK
- Status last verified
- Jan 2023
- First submitted
- 11 Oct 2007
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.
PubMed 17102659
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
- ClinicalTrials.gov ID
- NCT00543660
- Acronym / sponsor ID
- DSAEK / NIIOS.1998.04
- Conditions
- Corneal Dystrophies, Hereditary
- Keywords
- Corneal transplantation, Descemet membrane, endothelium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Netherlands Institute for Innovative Ocular SurgeryUniversity, hospital or other
- Collaborators
- Amnitrans Eyebank Rotterdam, Melles CorneaClinic Rotterdam
- Study start
- Mar 1998
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 Oct 2007 (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.
To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).
Detailed description
Please see above.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm DSEK | Experimental | Procedure: Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Intervention: DSEK |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Corneal endothelial disorders
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)Also: Descemet Stripping Endothelial Keratoplasty (DSEK), Please see www.niios.com | Procedure or surgery | Intervention arm DSEK |
Primary outcome
Best spectacle corrected visual acuity
Time frame: 1998 - 2018
1 secondary outcome
Corneal endothelial cell density
Time frame: 1998-2018
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 12 Jan 2023.
- Results publication: PubMed 17102659Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.
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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.
Gerrit RJ Melles, MD PhD principal investigator
Netherlands Institute for Innovative Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) in people with Corneal Dystrophies, Hereditary, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 12 Jan 2023. 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 Netherlands. 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?
Best spectacle corrected visual acuity (time frame: 1998 - 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00543660, which also lists 1 linked publication.
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 12 Jan 2023.