About this trial
This single-centre, prospective, controlled, non-interventional observational clinical study aims to characterize early postoperative corneal thickness behaviour after routine phacoemulsification cataract surgery in eyes with Fuchs endothelial corneal dystrophy (FECD) compared with non-FECD controls, using exclusively standard-of-care perioperative assessments. To compare central corneal thickness (CCT) six weeks postoperatively between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT.
All participants undergo routine phacoemulsification cataract surgery and routine perioperative assessments. Data are collected from the standard-of-care documentation at the following time points:
1. Preoperative baseline visit (routine cataract work-up) 2. Study specific postoperative follow-up at approximately 6 weeks. Each participant will attend a study-specific follow-up visit at 6 weeks postoperatively and contributes study-specific follow-up data up to this time point.
The routine clinical parameters assessed (as available per standard practice) include:
(A) Medical history / baseline characteristics and documentation of ocular/systemic comorbidities and topical medication.
(B) Best-corrected visual acuity (BCVA) (logMAR).
(C) Intraocular pressure (IOP) measured by Goldmann applanation tonometry (GAT).
(D) Slit-lamp examination (including assessment of corneal clarity/edema and anterior segment findings) with fundoscopy as routinely documented.
(E) Central corneal thickness (CCT) measurement using routine clinical devices. All measurements will be performed at a consistent time of day for each patient.
(F) Anterior segment optical coherence tomography (AS-OCT) using Casia2.
(G) Anterior segment Scheimpflug tomography (Pentacam Oculus AXL).
(H) Endothelial cell assessment or Endothelial Cell Count (ECC) examined with NIDEK® CEM-530 Specular Microscope:
* Cell Density (CD) or Cell Count. Expressed as Cells/mm² * Coefficient of Variation (CV), represents the degree of variation in cell size (Polymegethism) * Percentage (%) of six-sided (hexagon) cells (HEX) * Standard Deviation (SD) of the average cell area.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Signed written informed consent for participation and for use of routine clinical data in pseudonymised form.
Age ≥50 years at the time of cataract surgery.
Scheduled cataract surgery (unilateral/bilateral cataract).
No evidence of other ophthalmic diseases (e.g. macular pathology)
Disqualifiers
Corneal scars
Pseudoexfoliation (PEX) syndrome
Glaucoma
Uveitis
Trial population
This study will include approximately 98 eyes scheduled for routine phacoemulsification cataract surgery at the Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund (Vienna, Austria). The indication to perform cataract surgery will have been made prior to and independently of study participation. Participants will be enrolled from the routine cataract surgery population and allocated to one of two cohorts based on the presence or absence of Fuchs endothelial corneal dystrophy (FECD) as determined during standard preoperative assessment.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Central corneal thickness (CCT, µm) six weeks after routine phacoemulsification cataract surgery, compared between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT
The primary endpoint of this study is central corneal thickness (CCT, µm) six weeks after routine phacoemulsification cataract surgery, compared between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT.
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