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OpenTrials
Completed

NCT Number: NCT03687996

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

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.

Completed

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Key information

Conditions

Descemet's Stripping Automated Endothelial Keratoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with endothelial decompensation after penetrating keratoplasty
  • surgery realised by the same surgeon

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. visual acuity

    Time frame: change from visual acuity at 6 month

    pre and postoperative visual acuity in logmar

Secondary outcomes

  1. cornea thickness at 6 months

    Time frame: change from cornea thickness at 6 months

    the central cornea and graft thickness measured in OCT

  2. cornea thickness at 10 years

    Time frame: change from cornea thickness at 10 years

    the central cornea and graft thickness measured in OCT

  3. postoperative complications

    Time frame: month 6

    all the postoperative complications were collected

  4. visual acuity at 10 years

    Time frame: change from visual acuity at 10 years

    pre and postoperative visual acuity in logmar

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: MADE

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 27, 2018
Registry last updated
Feb 3, 2023

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.