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

Corneal Changes of Membranes Clinical Trial

— TransCor  

Official title:

Relationship Between Preoperative Corneal Thickness and Postoperative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03355911
• Other study ID #: 2016-07Obs-CHRMT
• Status: Completed
• Phase: N/A
• First received: November 23, 2017
• Last updated: December 4, 2017
• Start date: October 1, 2016
• Est. completion date: May 30, 2017

Study information

• Verified date: November 2017
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Changes of Membranes
• Corneal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)	LogMar	month 6