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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fuchs' Torsional Phaco Study

NCT00781027

Fuchs' Endothelial Dystrophy Phacoemulsification

COMPLETED PHASE4

Predictive Factors of Good Results After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK)

NCT04469933

Endothelial Corneal Dystrophy

COMPLETED

Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts

NCT06966167

Fuchs Endothelial Corneal Dystrophy Cataract

RECRUITING

SUCCESS Score Validation in Fuchs Dystrophy

NCT07265388

Fuchs Endothelial Corneal Dystrophy

RECRUITING

Combined Cataract Surgery and Planned Descemetorhexis

NCT02206594

Fuchs' Corneal Dystrophy Cataract

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fuchs' Endothelial Dystrophy Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cataract - FECD

Eyes with FECD undergoing cataract surgery

Phacoemulsification with intraocular lens implantation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phacoemulsification with intraocular lens implantation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No