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NCT04420429 Clinical Trial

The Effect Of Preoperative Parameters On Success After DMEK Surgery

Endothelial Dysfunction Clinical Trial

Official title:
The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04420429
Other study ID # BeyogluEREH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date July 10, 2022

Study information
Verified date July 2022
Source Beyoglu Eye Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.

Description:

In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date July 10, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK) - aged 18 old older Exclusion Criteria: - Patients with corneal pathology other than endothelial insufficiency - Glaucoma patients, - Patients who have previously had any keratoplasty procedure

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Descemet membrane endothelial keratoplasty (DMEK)
All participants underwent DMEK surgery

Locations
Country Name City State
Turkey Beyoglu Eye Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Beyoglu Eye Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Other Surgical complications Complications occurring during the surgery will be recorded. During surgery
Primary Change in visual acuity Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
Primary Change in endothelial cell density Change from baseline after surgery 1, 3, 6, and 12 months
Secondary Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
Secondary Change in anterior chamber depth Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
Secondary Change in axial length Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
Secondary Change in central pachymetry Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
Secondary Change in intraocular pressure Change from baseline Baseline and after surgery 1, 3, 6, and 12 months
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