Pratical Assessment of DSAEK in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Descemet's Stripping Automated Endothelial Keratoplasty Clinical Trial

— MADE  

Official title:

Pratical Assessment of Descemet'Sstripping Automated Endothelial Keratoplasty (DSAEK) in the Management of Endothelial Decompensation Following Penetrating Keratoplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687996
• Other study ID #: 2015-15Obs-CHRMT
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: July 31, 2016

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Reporting our anatomical and functional results and the possible complications of the first six Descemet's stripping endothelial keratoplasty (DSAEK) performed in our department secondary to endothelial decompensation after penetrating keratoplasty.

Description:

A retrospective and observational monocentric study fo six patients with DSAEK after prior penetrating keratoplasty (PK). The data collected are: demographic characteristics, ophthalmological comorbidities, initial indication of PK, delay between PK and DSAEK. Preoperative Visual Acuity and at 1, 3 and 6 months postoperative were collected in logmar for analysis. The central cornea and graft thickness measured in OCT as well as the postoperative complications were also collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 31, 2016
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• with endothelial decompensation after penetrating keratoplasty

• surgery realised by the same surgeon

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Descemet's Stripping Automated Endothelial Keratoplasty

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	visual acuity	pre and postoperative visual acuity in logmar	change from visual acuity at 6 month
Secondary	cornea thickness at 6 months	the central cornea and graft thickness measured in OCT	change from cornea thickness at 6 months
Secondary	cornea thickness at 10 years	the central cornea and graft thickness measured in OCT	change from cornea thickness at 10 years
Secondary	postoperative complications	all the postoperative complications were collected	month 6
Secondary	visual acuity at 10 years	pre and postoperative visual acuity in logmar	change from visual acuity at 10 years