Postoperative CCT in FECD vs. Non-FECD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorVienna Hospital Association

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

Qualifiers

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 design

Treatments tested in this trial

  • Not listed

Trial groups

98 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators