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

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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status

Completed

Conditions

Cataract
Fuchs' Endothelial Dystrophy

Treatments

Procedure: Phacoemulsification with intraocular lens implantation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

68 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

68 participants in 1 patient group

Cataract - FECD
Description:
Eyes with FECD undergoing cataract surgery
Treatment:
Procedure: Phacoemulsification with intraocular lens implantation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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