The Effect Of Preoperative Parameters On Success After DMEK Surgery

Completed

• Conditions: Pseudophakic Bullous Keratopathy; Endothelial Dysfunction; Fuchs' Endothelial Dystrophy; Descemet's Membrane; Defect; Angle's Classification; Herpetic Keratitis
• Interventions: Procedure: Descemet membrane endothelial keratoplasty (DMEK)

• Registration Number: NCT04420429
• Lead Sponsor: Beyoglu Eye Research and Education Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-05-16
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Primary Completion: 2021-12-31
• Status Verified: 2022-07
• Study Completion: 2022-07-10
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Descemet membrane endothelial keratoplasty (DMEK)	All patients

Primary Outcome Measures

Name	Time	Method
Change in endothelial cell density	after surgery 1, 3, 6, and 12 months	Change from baseline
Change in visual acuity	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline

Secondary Outcome Measures

Name	Time	Method
Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline
Change in anterior chamber depth	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline
Change in axial length	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline
Change in central pachymetry	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline
Change in intraocular pressure	Baseline and after surgery 1, 3, 6, and 12 months	Change from baseline

Trial Locations

Locations (1)

Beyoğlu Eye Training and Research Hospital; 🇹🇷 Istanbul, Turkey