Corneal TransplantationNCT01206127
DSAEK- Postoperative Positioning and Transplant Dislocation
A study testing Postoperative positioning: Bed rest and Postoperative positioning: Sitting up in people with Corneal Transplantation and Descemet Stripping Automated Endothelial Keratoplasty, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation, Descemet Stripping Automated Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy
- What is being tested?
- Postoperative positioning: Bed rest and Postoperative positioning: Sitting up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corneal dystrophy requiring corneal transplantation
- Patients written permission
- Pseudophakia
Who cannot join
- Uncontrolled glaucoma
- Phakia or aphakia
- Shallow anterior chamber
- Fibrotic cornea
- Demented patients
- Claustrophobic patients
- Patients that do not want to participate
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Departement of Ophthalmology, Oslo University Hospital, Norway
Oslo, Oslo, N-0407
Liv Drolsum, Prof.,MD,PhD, +47 22 11 85 45, LivKari.Drolsum@ulleval.no
Marit Sæthre, MD, PhD, +47 22 11 85 45, marit.sathre@medisin.uio.no
About this study
Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.
The purpose of this study is to investigate how immediate postoperative positioning of the patient affects the dislocation rate of the corneal graft. Since this is a new surgical method, little scientific documentation has been published in this area.
Read the detailed description
Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.
To get the graft in the right position inside the eyes anterior chamber, the anterior chamber is fully filled with air, and the patient is placed in a supine position looking facing up for different amount of time depending on the surgeon. In this way the air bubble will press the graft in the right position and prevent dislocation. Our experience is that since the anterior chamber of the eye already is fully filled with air, it does not matter how the patient is positioned postoperatively regarding graft dislocation.
Our hypothesis is that the immediate postoperative positioning is insignificant. If this can be significantly proved this may enhance the patients comfort postoperatively.
- Conditions
- Corneal Transplantation, Descemet Stripping Automated Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy, Corneal Dystrophies, Hereditary
- Being tested
- Postoperative positioning: Bed rest, Postoperative positioning: Sitting up
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative positioning: Bed restOther
Patients in this group should be lying down facing up 2 hours postoperatively
Postoperative positioning: Sitting upOther
Patients in this group should be sitting up in a chair 2 hours postoperative
| Study group | Role | What they receive |
|---|---|---|
| Postoperative positioning: Bed rest | Other | Patients in this group must be lying down facing up 2 hours postoperatively Receives: Other: Postoperative positioning: Bed rest |
| Postoperative positioning: Sitting up | Other | Patients in this group should be sitting up in a chair 2 hours postoperatively Receives: Other: Postoperative positioning: Sitting up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft dislocation measured by slit lamp examination
Graft dislocation is checked 2 hours postoperatively, they day after the surgery, 1 week after, 1 month, and then every 3. month for 1 year, and then every 6. months for 5 years.
Measured: 5 years
Secondary outcomes (3)
Intraocular pressure (IOP)
The intraocular pressure (IOP) is measured at every postoperative control
Measured: 5 years
Visual Acuity
Visual Acuity is measured at every postoperative control
Measured: 5 years
Endothelial cell count of the graft
Endothelial cell count of the graft is measured at every postoperative control
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Corneal TransplantationStudies of the same condition, open and under way.
- More trials run by Oslo 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liv Drolsum, Prof.,MD,PhD, Study director, Department of Ophthalmology, Oslo University Hospital, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206127
- Sponsor's protocol ID
- 239-08/344c(REK)-1
- Status last verified
- Sep 2010
- First submitted
- 20 Sep 2010
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Price MO, Gorovoy M, Benetz BA, Price FW Jr, Menegay HJ, Debanne SM, Lass JH. Descemet's stripping automated endothelial keratoplasty outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology. 2010 Mar;117(3):438-44. doi: 10.1016/j.ophtha.2009.07.036. Epub 2010 Jan 19.
PubMed 20031230Price MO, Giebel AW, Fairchild KM, Price FW Jr. Descemet's membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology. 2009 Dec;116(12):2361-8. doi: 10.1016/j.ophtha.2009.07.010. Epub 2009 Oct 28.
PubMed 19875170Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
PubMed 19417653
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DSAEK- Postoperative Positioning and Transplant Dislocation
- ClinicalTrials.gov ID
- NCT01206127
- Acronym / sponsor ID
- 239-08/344c(REK)-1
- Conditions
- Corneal Transplantation, Descemet Stripping Automated Endothelial Keratoplasty, Fuchs' Endothelial Dystrophy, Corneal Dystrophies, Hereditary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Sep 2010 (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.
Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.
The purpose of this study is to investigate how immediate postoperative positioning of the patient affects the dislocation rate of the corneal graft. Since this is a new surgical method, little scientific documentation has been published in this area.
Detailed description
Corneal transplant is a surgical procedure where a damaged or diseased cornea is replaced by donated corneal tissue (the graft) in its entirety (penetrating keratoplasty) or in part (lamellar keratoplasty). One type of lamellar keratoplasty is DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty), where only the damaged posterior section of the cornea is replaced.
To get the graft in the right position inside the eyes anterior chamber, the anterior chamber is fully filled with air, and the patient is placed in a supine position looking facing up for different amount of time depending on the surgeon. In this way the air bubble will press the graft in the right position and prevent dislocation. Our experience is that since the anterior chamber of the eye already is fully filled with air, it does not matter how the patient is positioned postoperatively regarding graft dislocation.
Our hypothesis is that the immediate postoperative positioning is insignificant. If this can be significantly proved this may enhance the patients comfort postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative positioning: Bed rest | Other | Other: Postoperative positioning: Bed restPatients in this group must be lying down facing up 2 hours postoperatively |
| Postoperative positioning: Sitting up | Other | Other: Postoperative positioning: Sitting upPatients in this group should be sitting up in a chair 2 hours postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Corneal dystrophy requiring corneal transplantation
- Patients written permission
- Pseudophakia
Key exclusion criteria (7 listed)
- Uncontrolled glaucoma
- Phakia or aphakia
- Shallow anterior chamber
- Fibrotic cornea
- Demented patients
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 |
|---|---|---|
| Postoperative positioning: Bed restPatients in this group should be lying down facing up 2 hours postoperatively | Other | Postoperative positioning: Bed rest |
| Postoperative positioning: Sitting upPatients in this group should be sitting up in a chair 2 hours postoperative | Other | Postoperative positioning: Sitting up |
Primary outcome
Graft dislocation measured by slit lamp examination
Time frame: 5 years
Graft dislocation is checked 2 hours postoperatively, they day after the surgery, 1 week after, 1 month, and then every 3. month for 1 year, and then every 6. months for 5 years.
3 secondary outcomes
Intraocular pressure (IOP)
Time frame: 5 years
Visual Acuity
Time frame: 5 years
Endothelial cell count of the graft
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2010.
- Background: PubMed 20031230Price MO, Gorovoy M, Benetz BA, Price FW Jr, Menegay HJ, Debanne SM, Lass JH. Descemet's stripping automated endothelial keratoplasty outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology. 2010 Mar;117(3):438-44. doi: 10.1016/j.ophtha.2009.07.036. Epub 2010 Jan 19.
- Background: PubMed 19875170Price MO, Giebel AW, Fairchild KM, Price FW Jr. Descemet's membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology. 2009 Dec;116(12):2361-8. doi: 10.1016/j.ophtha.2009.07.010. Epub 2009 Oct 28.
- Background: PubMed 19417653Dapena I, Ham L, Melles GR. Endothelial keratoplasty: DSEK/DSAEK or DMEK--the thinner the better? Curr Opin Ophthalmol. 2009 Jul;20(4):299-307. doi: 10.1097/ICU.0b013e32832b8d18.
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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.
Liv Drolsum, Prof.,MD,PhD study director
Department of Ophthalmology, Oslo University Hospital, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative positioning: Bed rest and Postoperative positioning: Sitting up in people with Corneal Transplantation and Descemet Stripping Automated Endothelial Keratoplasty, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2010. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liv Drolsum, Prof,MD,PhD (+47 22 11 85 45, LivKari.Drolsum@ulleval.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft dislocation measured by slit lamp examination (time frame: 5 years). 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 NCT01206127, which also lists 3 linked publications.
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 21 Sep 2010.