NCT01206127

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

7.3 years

First QC Date

September 20, 2010

Last Update Submit

September 20, 2010

Conditions

Corneal TransplantationDescemet Stripping Automated Endothelial KeratoplastyFuchs' Endothelial DystrophyCorneal Dystrophies, Hereditary

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intraocular pressure (IOP)

    5 years

  • Visual Acuity

    5 years

  • Endothelial cell count of the graft

    5 years

Study Arms (2)

Postoperative positioning: Bed rest

OTHER

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

Other: Postoperative positioning: Bed rest

Postoperative positioning: Sitting up

OTHER

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

Other: Postoperative positioning: Sitting up

Interventions

Postoperative positioning: Bed restOTHER

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

Postoperative positioning: Bed rest
Postoperative positioning: Sitting upOTHER

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

Postoperative positioning: Sitting up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Corneal dystrophy requiring corneal transplantation
  • Patients written permission
  • Pseudophakia

You may not qualify if:

  • Uncontrolled glaucoma
  • Phakia or aphakia
  • Shallow anterior chamber
  • Fibrotic cornea
  • Demented patients
  • Claustrophobic patients
  • Patients that do not want to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Ophthalmology, Oslo University Hospital, Norway

Oslo, Oslo County, N-0407, Norway

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20031230BACKGROUND

  • 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.

    PMID: 19875170BACKGROUND

  • 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.

    PMID: 19417653BACKGROUND

MeSH Terms

Conditions

Fuchs' Endothelial DystrophyCorneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Liv Drolsum, Prof.,MD,PhD

    Department of Ophthalmology, Oslo University Hospital, Norway

    STUDY DIRECTOR

Central Study Contacts

Liv Drolsum, Prof,MD,PhD

CONTACT

+47 22 11 85 45LivKari.Drolsum@ulleval.no

Marit Sæthre, MD, PhD

CONTACT

+47 22 11 85 45marit.sathre@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

NO(1)