Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- Rate of progression to endothelial keratoplasty (DMEK) [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
- Best spectacle corrected visual acuity [2 months after cataract surgery]
Measured in logMAR scale
- Corneal tomography changes [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.
- Postoperative refraction [2 months after cataract surgery and after DMEK surgery]
Postoperative subjective refraction (sphere, cylinder, axis)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
FECD grade 2 or worse (modified Krachmer scale)
-
Cataract requiring surgery
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Epithelial corneal edema evident in slit lamp examination
Exclusion Criteria:
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Concurrent anterior corneal dystrophy
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History of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease.
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Non-collaborative or unable to receive postoperative care at our institution.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Ramón y Cajal | Madrid | Spain | 28034 |
Sponsors and Collaborators
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Investigators
- Principal Investigator: Francisco Arnalich Montiel, MD,PhD, H.U. Ramón y Cajal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 252/17