DSAEK- Postoperative Positioning and Transplant Dislocation

University of Oslo (UIO)

Status: Unknown

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

Treatments: Other: Postoperative positioning: Bed rest; Other: Postoperative positioning: Sitting up

Study type: Interventional

Funder types: Other

Identifiers

NCT01206127

239-08/344c(REK)-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Postoperative positioning: Bed rest

Other group

Description:

Patients in this group must be lying down facing up 2 hours postoperatively

Treatment:

Other: Postoperative positioning: Bed rest

Postoperative positioning: Sitting up

Other group

Description:

Patients in this group should be sitting up in a chair 2 hours postoperatively

Treatment:

Other: Postoperative positioning: Sitting up