Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant

Completed

• Conditions: Corneal Changes of Membranes

• Registration Number: NCT03355911
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)

Detailed Description

Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged \> 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-23
• Study First Posted: 2017-11-28
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 113

Inclusion Criteria

• Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:

  • Fuchs dystrophy,
  • pseudophakic bullous decompensation
  • or other endothelial dysfunction corneal

Exclusion Criteria

• were a history of penetrating keratoplasty in the indicated eye
• the technical inability of preoperative CCT measurement
• the need for a penetrating keratoplasty following endothelial graft failure
• severe postoperative complications resulting in unquantifiable visual acuity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)	month 6	LogMar