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OpenTrials
Completed

NCT Number: NCT02883855

Impact of Graft Thickness on Visual Gain After Descemet's Stripping Automated Endothelial Keratoplasty

The aim of this study to determinate if there is a correlation between visual acuity gain in patients who underwent a Descemet's stripping automated endothelial keratoplasty (DSAEK) corneal keratoplasty and the central thickness of the graft.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Were included in this study eyes who underwent a DSAEK for endothelial dysfunctions indication (mainly acquired after phacoemulsification or for Fuchs dystrophy) between early 2012 and mid 2015 at CHR Metz-Thionville (Mercy Hospital) Were excluded eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases. Central graft thickness was measured in Anterior Segment Optical Coherence Topography (AS-OCT RS-3000 Nidek). Visual acuity gain was defined by the differential between pre-operative visual acuity (VA) and post operative best corrected visual acuity (BCVA) obtained during post-operative visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with endothelial dysfunctions indication

Exclusion criteria

  • eyes presenting pathologies (e.g. Age-Related Macular Degeneration, or diabetic macular edema) which are known to induce visual acuity decrease, non-related to the success of the graft and graft failure cases

Treatment and study plan

Primary outcomes

  1. Visual acuity gain after DSAEK lamellar keratoplasty

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Acronym: EP-GREFF

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Sep 15, 2016

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.