Clinical trial NCT04527523: Descemet Membrane Endothelial Keratoplasty vs. Descemet's Stripping With Endothelial Keratoplasty vs. Descemet Stripping Only
Official title: Incidence of Post-operative Cystoid Macular Edema: A Prospective Study Comparing DMEK, DSEK, and DSO
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cystoid Macular Edema
Fuchs Dystrophy
Keywords: endothelial transplants
endothelial dysfunction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Post-Op CME
timeFrame: 6 weeks post-operative
measure: Incidence of Post-Op CME
timeFrame: 3 months post-operative
measure: Severity of Post-Op CME
timeFrame: 6 weeks post-operative
measure: Severity of Post-Op CME
timeFrame: 3 months post-operative
Secondary outcomes:
measure: Graft Detachment
timeFrame: 6 weeks and 3 months post-operative
measure: Re-bubbling Procedure
timeFrame: 6 weeks and 3 months post-operative
measure: Infection
timeFrame: 6 weeks and 3 month post-operative
measure: Final Visual Acuity
timeFrame: 3 months post-operative
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Matthew Giegengack
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.