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OpenTrials
Completed

NCT Number: NCT03685734

Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty

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).

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Key information

Conditions

Corneal Endothelial Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual acuity

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: VO-DSAEK

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 26, 2018
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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