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.