Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only

Terminated

• Conditions: Cystoid Macular Edema; Fuchs Dystrophy
• Interventions: Diagnostic Test: Optical Coherence Tomography

• Registration Number: NCT04527523
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).

Detailed Description

Patients that are undergoing any of these procedures will be asked if they are willing to have a baseline pre-operative Optical Coherence Tomography (OCT) scan completed within 4 weeks of surgery. Additional OCT scans will be collected during routine follow up care. It is hypothesized that the rates of CME will be lower with DSO compared to DMEK and DSEK.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-26
• Study Start: 2020-11-21
• Primary Completion: 2022-08-24
• Study Completion: 2022-08-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK

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Exclusion Criteria

• Patients that do not have an optical coherence tomography measurement pre- operatively
• Patients that don't have an optical coherence tomography measurement post- operatively
• Patients with a previous history of uncontrolled macular edema

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endothelial Dysfunction Cohort	Optical Coherence Tomography	All patients enrolled in the study will receive a baseline Optical Coherence Tomography scan (OCT) within 4 weeks prior to surgery. Two additional OCT scan will be performed 6 weeks and 3 months after surgery.

Primary Outcome Measures

Name	Time	Method
Severity of Post-Op CME	3 months post-operative	The severity of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO that experience Cystoid Macular Edema after surgery - measured by net change of Central Foveal Thickness on Optical Coherence Tomography (OCT- is an imaging technique that uses low-coherence light to capture micrometer-resolution, two- and three-dimensional images from within optical scattering media, e.g., biological tissue)
Incidence of Post-Op CME	3 months post-operative	The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.

Secondary Outcome Measures

Name	Time	Method
Graft Detachment	6 weeks and 3 months post-operative	Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant.
Infection	6 weeks and 3 month post-operative	The incidence (number of Subjects) of post-operative infection will be evaluated.
Re-bubbling Procedure	6 weeks and 3 months post-operative	The incidence (number of Subjects) of re-bubbling procedures performed post-operatively will be evaluated.
Final Visual Acuity	3 months post-operative	The Snellen Visual Acuity test - This means that the test subject sees the same line of letters at 20 feet that person with normal vision sees at 20 feet. 20/40 vision means that the test subject sees at 20 feet what a person with normal vision sees at 40 feet.

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States