Postoperative CCT in FECD vs. Non-FECD

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:

1. Medical history / baseline characteristics and documentation of ocular/systemic comor-bidities and topical medication 2. Best-corrected visual acuity (BCVA) (logMAR). 3. Intraocular pressure (IOP) measured by Goldmann applanation tonometry (GAT). 4. Slit-lamp examination (including assessment of corneal clarity/edema and anterior seg-ment findings) with fundoscopy as routinely documented. 5. Central corneal thickness (CCT) measurement using routine clinical devices. All meas-urements will be performed at a consistent time of day for each patient. 6. Anterior segment OCT (CASIA2). 7. Anterior segment Scheimpflug tomography (Pentacam Oculus AXL) 8. Endothelial cell assessment (ECC, CV, AVG, HEX, SD) examined with NIDEK® CEM-530 Specular Microscope

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Key information

Conditions

Fuchs Endothelial Corneal Dystrophy Cataract Cataract (Post-operative Cataract Surgery Follow-up) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a single-centre, prospective, controlled, non-interventional observational clinical study conducted at the Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund, Vienna, Aus-tria.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Cohort-specific inclusion:

FECD cohort: Clinical diagnosis of FECD based on slit-lamp findings, graded accord-ing to Krachmer et al. (1978) as documented in routine care.
Control cohort: No clinical evidence of corneal endothelial disease at baseline (no signs consistent with FECD or other endothelial pathology) as documented in routine care.

Exclusion criteria

Corneal scars
Pseudoexfoliation (PEX) syndrome
Glaucoma
Uveitis
Diabetic retinopathy
Other relevant ophthalmic disorders (e.g. retinal degeneration, macular or corneal pa-thologies)
Previous intraocular surgery (including laser procedures)
Ocular trauma (within the past 6 months)
Pregnancy (if applicable, pregnancy must be excluded by a β-hCG test)
CCT > 625μm

Treatment and study plan

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

Time frame: 6 weeks

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.

Sponsors and collaborators

Lead sponsor

Vienna Hospital Association

Other Gov

Registry information

Official study title

Central Corneal Thickness After Cataract Surgery in Eyes With Fuchs Endothelial Corneal Dystrophy (FECD) Compared With Non-FECD Eyes: A Prospective, Controlled, Non-interventional Observational Clinical Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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