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

Cataract Clinical Trial

Official title:

Escala de Riesgo de descompensación Corneal en cirugía de Catarata en Pacientes Con Distrofia Corneal de Fuchs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072029
• Other study ID #: 252/17
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: April 2019
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Phacoemulsification with intraocular lens implantation
Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of progression to endothelial keratoplasty (DMEK)	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)	2 months after cataract surgery
Secondary	Best spectacle corrected visual acuity	Measured in logMAR scale	2 months after cataract surgery
Secondary	Corneal tomography changes	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.	2 months after cataract surgery
Secondary	Postoperative refraction	Postoperative subjective refraction (sphere, cylinder, axis)	2 months after cataract surgery and after DMEK surgery