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Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04072029
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study Description
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Brief Summary:

Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised.

Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD.

Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.


Condition or disease Intervention/treatment
Fuchs' Endothelial Dystrophy Cataract Procedure: Phacoemulsification with intraocular lens implantation

Study Design
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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Escala de Riesgo de descompensación Corneal en cirugía de Catarata en Pacientes Con Distrofia Corneal de Fuchs
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cataract - FECD
Eyes with FECD undergoing cataract surgery
 Procedure: Phacoemulsification with intraocular lens implantation
Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)


Outcome Measures
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Primary Outcome Measures :
  1. Rate of progression to endothelial keratoplasty (DMEK) [ Time Frame: 2 months after cataract surgery ]
    Evaluation of baseline parameters that could predict the need for DMEK taking into account best espetacle corrected visual acuity and visual symptoms attributable to FECD and corneal edema (worse vision in the mornings, starburst or halos at night or subjective impairment of vision interfering with daily routine activities such as reading printed paper, looking at screens or driving)


Secondary Outcome Measures :
  1. Best spectacle corrected visual acuity [ Time Frame: 2 months after cataract surgery ]
    Measured in logMAR scale

  2. Corneal tomography changes [ Time Frame: 2 months after cataract surgery ]
    Changes in pachymetric parameters (corneal thickness at the apex, center of the pupil, thinnest point and relative pachymetry) and densitometry (central corneal light backscatter) measured by Pentacam Scheimpflug tomograpy.

  3. Postoperative refraction [ Time Frame: 2 months after cataract surgery and after DMEK surgery ]
    Postoperative subjective refraction (sphere, cylinder, axis)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred for cataract surgery to the Cornea Department
Criteria

Inclusion Criteria:

  • FECD grade 2 or worse (modified Krachmer scale)
  • Cataract requiring surgery
  • Epithelial corneal edema evident in slit lamp examination

Exclusion Criteria:

  • Concurrent anterior corneal dystrophy
  • History of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease.
  • Non-collaborative or unable to receive postoperative care at our institution.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04072029


Locations
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Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
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Principal Investigator: Francisco Arnalich Montiel, MD,PhD H.U. Ramón y Cajal
More Information
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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT04072029    
Other Study ID Numbers: 252/17
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Fuchs' Endothelial Dystrophy
Lens Diseases
Eye Diseases
 Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn