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

NCT04527523 | Terminated

• 1 other identifier: IRB00067948
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystoid Macular Edema; Fuchs Dystrophy

Keywords

endothelial transplants; endothelial dysfunction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Graft Detachment

  6 weeks and 3 months post-operative

• Re-bubbling Procedure

  6 weeks and 3 months post-operative

• Infection

  6 weeks and 3 month post-operative

• Final Visual Acuity

  3 months post-operative

Study Arms (1)

Endothelial Dysfunction Cohort

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.

Diagnostic Test: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DIAGNOSTIC_TEST

OCT is an imaging method that uses light waves to create images of the retina.

Also known as: OCT

Endothelial Dysfunction Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with endothelial dysfunction that require treatment, and are being evaluated for Descemet Stripping Only (DSO), Descemet Membrane Endothelial Keratoplasty (DMEK) or Descemet's Stripping Automated Endothelial Keratoplasty (DSEK)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• 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.

  PMID: 30973407 BACKGROUND

• 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.

  PMID: 29298168 BACKGROUND

• 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.

  PMID: 25299425 BACKGROUND

• 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.

  PMID: 26186374 BACKGROUND

MeSH Terms

Conditions

Macular Edema; Fuchs' Endothelial Dystrophy

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Matthew Giegengack

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: November 21, 2020
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)