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
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Sponsor:
Centre Hospitalier Régional Metz-Thionville
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville
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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 |
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Corneal Changes of Membranes |
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.
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 :
- 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:
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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
No Contacts or Locations Provided
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |