Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty

Corneal Endothelial Disorder Clinical Trial

— VO-DSAEK  

Official title:

Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty for Corneal Endothelial Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685734
• Other study ID #: 2015-13Obs-CHRMT
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 1, 2016

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).

Description:

Since 2006, the technique by removing the Descemet membrane from the recipient cornea was renamed Descemet stripping automated endothelial keratoplasty (DSAEK). In recent years, DSAEK techniques have evolved, favoring increasingly thinner and finer grafts, known as ultrathin DSAEK (UT DSAEK), with the aim of obtaining better visual results.

Endothelial keratoplasty is now the most common surgical procedure used to treat endothelial dysfunction. The current study focused on assessing both objective and subjective visual quality outcomes following DSAEK.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 1, 2016
• Est. primary completion date: June 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical eligibility for DSAEK

• Informed written consent

• Successful completion of DSAEK procedure

• Postoperative follow-up at least 1 year

• Ability to respond to the questionnaire

Exclusion Criteria:

• Patients with clinical edematous cornea

• With significant stromal opacity

• With major disturbances of ocular surface

• Previous corneal surgery

Related Conditions & MeSH terms

• Corneal Diseases
• Corneal Endothelial Disorder

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	Scored with reference to the logarithm of the minimum angle of resolution (logMAR) and its variation in line gain.	1 year