DSAEK- Postoperative Positioning and Transplant Dislocation

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

DSAEK- Postoperative Positioning and Transplant Dislocation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01206127
• Other study ID #: 239-08/344c(REK)-1
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 20, 2010
• Start date: September 2010
• Est. completion date: January 2018

Study information

• Verified date: September 2010
• Source: Oslo University Hospital
• Contact: Liv Drolsum, Prof,MD,PhD
• Phone: +47 22 11 85 45
• Email: LivKari.Drolsum[@]ulleval.no
• Is FDA regulated: No
• Health authority: Norway: Oslo University Hospital, Ulleval, department of research (FoU)Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of HealthNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Corneal dystrophy requiring corneal transplantation

• Patients written permission

• Pseudophakia

Exclusion Criteria:

• Uncontrolled glaucoma

• Phakia or aphakia

• Shallow anterior chamber

• Fibrotic cornea

• Demented patients

• Claustrophobic patients

• Patients that do not want to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Corneal Transplantation
• Descemet Stripping Automated Endothelial Keratoplasty
• Dislocations
• Fuchs' Endothelial Dystrophy

Intervention

Other:
• Postoperative positioning: Bed rest
Patients in this group should be lying down facing up 2 hours postoperatively
• Postoperative positioning: Sitting up
Patients in this group should be sitting up in a chair 2 hours postoperative

Locations

Country	Name	City	State
Norway	Departement of Ophthalmology, Oslo University Hospital, Norway	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Dapena 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. Review. — View Citation

Price 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years	No
Secondary	Intraocular pressure (IOP)	The intraocular pressure (IOP) is measured at every postoperative control	5 years	No
Secondary	Visual Acuity	Visual Acuity is measured at every postoperative control	5 years	No
Secondary	Endothelial cell count of the graft	Endothelial cell count of the graft is measured at every postoperative control	5 years	No