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NCT03355924 Clinical Trial

DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

Cataract Clinical Trial

— CISIPHE  

Official title:
DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03355924
Other study ID # 2016-08Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2016
Est. completion date May 30, 2017

Study information
Verified date November 2017
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

Description:

The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date May 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients who underwent DMEK combined or not with cataract surgery Exclusion Criteria: - patients with other ocular comorbidity, and those who had graft after a first graft failure

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome
Type Measure Description Time frame Safety issue
Primary Best visual acuity logMar Month 12
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