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

Cystoid Macular Edema Clinical Trial

Official title:

Incidence of Post-operative Cystoid Macular Edema: A Prospective Study Comparing DMEK, DSEK, and DSO

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04527523
• Other study ID #: IRB00067948
• Status: Terminated
• Start date: November 21, 2020
• Est. completion date: August 24, 2022

Study information

• Verified date: January 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 24, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Cystoid Macular Edema
• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy
• Macular Edema

Intervention

Diagnostic Test:
• Optical Coherence Tomography
OCT is an imaging method that uses light waves to create images of the retina.

Locations

Country	Name	City	State
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270. — View Citation

Inoda S, Hayashi T, Takahashi H, Oyakawa I, Yokogawa H, Kobayashi A, Kato N, Kawashima H. Risk Factors for Cystoid Macular Edema After Descemet Membrane Endothelial Keratoplasty. Cornea. 2019 Jul;38(7):820-824. doi: 10.1097/ICO.0000000000001950. — View Citation

Kocaba V, Mouchel R, Fleury J, Marty AS, Janin-Manificat H, Maucort-Boulch D, Burillon C. Incidence of Cystoid Macular Edema After Descemet Membrane Endothelial Keratoplasty. Cornea. 2018 Mar;37(3):277-282. doi: 10.1097/ICO.0000000000001501. — View Citation

Koenig SB. Planned Descemetorhexis Without Endothelial Keratoplasty in Eyes With Fuchs Corneal Endothelial Dystrophy. Cornea. 2015 Sep;34(9):1149-51. doi: 10.1097/ICO.0000000000000531. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Post-Op CME	The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.	6 weeks post-operative
Primary	Incidence of Post-Op CME	The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.	3 months post-operative
Primary	Severity of Post-Op CME	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)	6 weeks post-operative
Primary	Severity of Post-Op CME	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)	3 months post-operative
Secondary	Graft Detachment	Frequency (number of Subjects) of post-operative graft detachment will be evaluated in patients that receive a corneal endothelial transplant.	6 weeks and 3 months post-operative
Secondary	Re-bubbling Procedure	The incidence (number of Subjects) of re-bubbling procedures performed post-operatively will be evaluated.	6 weeks and 3 months post-operative
Secondary	Infection	The incidence (number of Subjects) of post-operative infection will be evaluated.	6 weeks and 3 month post-operative
Secondary	Final Visual Acuity	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.	3 months post-operative