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

NCT ID: NCT04527523

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-21

Study Completion Date

2022-08-24

Brief Summary

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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

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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.

Conditions

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Cystoid Macular Edema Fuchs Dystrophy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optical Coherence Tomography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Optical Coherence Tomography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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OCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Giegengack

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Locations

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Wake Forest Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30973407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29298168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25299425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26186374 (View on PubMed)

Other Identifiers

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IRB00067948

Identifier Type: -

Identifier Source: org_study_id

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