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

This trial accepts healthy volunteers

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 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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

98 Participants
are grouped into 2 trial groups
Group A: Patients with Fuchs endothelial corneal dystrophy (FECD)
Group B: Non-FECD

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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