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Impact of Graft Thickness on Visual Gain After Descemet's Stripping Automated Endothelial Keratoplasty (EP-GREFF)

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ClinicalTrials.gov Identifier: NCT02883855
Recruitment Status : Completed
First Posted : August 30, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
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.

Condition or disease
DSAEK Patient

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016



Primary Outcome Measures :
  1. Visual acuity gain after DSAEK lamellar keratoplasty [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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

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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT02883855    
Other Study ID Numbers: 2015-08Obs-CHRMT
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: August 2016