DSAEK- Postoperative Positioning and Transplant Dislocation

Not Applicable

• Conditions: Corneal Transplantation; Descemet Stripping Automated Endothelial Keratoplasty; Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary

• Registration Number: NCT01206127
• Lead Sponsor: Oslo University Hospital

Brief 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.

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 Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Last Update Submitted: 2010-09-20
• Study First Posted: 2010-09-21
• Last Update Posted: 2010-09-21
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Graft dislocation measured by slit lamp examination	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Departement of Ophthalmology, Oslo University Hospital, Norway; 🇳🇴 Oslo, Norway