DSAEK- Postoperative Positioning and Transplant Dislocation

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.

Study Overview

• Status: Unknown
• Conditions: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy; Corneal Transplantation; Descemet Stripping Automated Endothelial Keratoplasty
• Intervention / Treatment: Other: Postoperative positioning: Bed rest; Other: Postoperative positioning: Sitting up

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liv Drolsum, Prof,MD,PhD; Phone Number: +47 22 11 85 45; Email: LivKari.Drolsum@ulleval.no
• Study Contact Backup: Name: Marit Sæthre, MD, PhD; Phone Number: +47 22 11 85 45; Email: marit.sathre@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway, N-0407
    • Recruiting
    • Departement of Ophthalmology, Oslo University Hospital, Norway
    • Contact: Marit Sæthre, MD, PhD; Phone Number: +47 22 11 85 45; Email: marit.sathre@medisin.uio.no
    • Contact: Liv Drolsum, Prof.,MD,PhD; Phone Number: +47 22 11 85 45; Email: LivKari.Drolsum@ulleval.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Postoperative positioning: Bed rest; Patients in this group must be lying down facing up 2 hours postoperatively	Other: Postoperative positioning: Bed rest; Patients in this group should be lying down facing up 2 hours postoperatively
Other: Postoperative positioning: Sitting up; Patients in this group should be sitting up in a chair 2 hours postoperatively	Other: Postoperative positioning: Sitting up; Patients in this group should be sitting up in a chair 2 hours postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP)	The intraocular pressure (IOP) is measured at every postoperative control	5 years
Visual Acuity	Visual Acuity is measured at every postoperative control	5 years
Endothelial cell count of the graft	Endothelial cell count of the graft is measured at every postoperative control	5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Director: Liv Drolsum, Prof.,MD,PhD, Department of Ophthalmology, Oslo University Hospital, Norway

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 20, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 20, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 239-08/344c(REK)-1