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Preoperative Corneal Thickness and Postoperative Visual Outcomes After Posterior Lamellar Corneal Transplant (TransCor)

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ClinicalTrials.gov Identifier: NCT03355911
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Brief Summary:
To evaluate the impact of preoperative corneal thickness on visual outcomes following Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK)

Condition or disease
Corneal Changes of Membranes

Detailed Description:
Patients underwent DSAEK or DMEK for endothelial dysfunction, from October 2013 to November 2016. Patients aged > 18 years and with an indication for posterior lamellar graft surgery, such as Fuchs dystrophy, were included. Exclusion criteria included a history of penetrating keratoplasty in the study eye and a need for a penetrating keratoplasty following endothelial graft failure. Visual acuity, central corneal thickness (CCT) and graft thickness were measured preoperatively, and at postoperative day 7 and months 1, 3 and 6.

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between Preoperative Corneal Thickness and Postoperative
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017



Primary Outcome Measures :
  1. Descemet's stripping endothelial keratoplasty (DSAEK) or Descemet membrane endothelial keratoplasty (DMEK) [ Time Frame: month 6 ]
    LogMar



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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
patients underwent posterior lamellar graft during the study period.
Criteria

Inclusion Criteria:

  • Clinically indicated need for posterior lamellar graft surgery (DSAEK or DMEK) such as:

    • Fuchs dystrophy,
    • pseudophakic bullous decompensation
    • or other endothelial dysfunction corneal

Exclusion Criteria:

  • were a history of penetrating keratoplasty in the indicated eye
  • the technical inability of preoperative CCT measurement
  • the need for a penetrating keratoplasty following endothelial graft failure
  • severe postoperative complications resulting in unquantifiable visual acuity
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT03355911    
Other Study ID Numbers: 2016-07Obs-CHRMT
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No