Postoperative CCT in FECD vs. Non-FECD

NCT07731945 | Not Yet Recruiting

• 1 other identifier: MA15-EK26-046-0426
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Fuchs Endothelial Corneal Dystrophy; Cataract (Post-operative Cataract Surgery Follow-up)

Keywords

Postoperative CCT; Fuchs Endothelial Corneal Dystrophy; FECD; CCT in FECD; Cataract Surgery FECD

Outcome Measures

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.

  6 weeks

Study Arms (2)

FECD

Patients with FECD

Non-FECD

Patients without FECD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include approximately 98 eyes scheduled for routine phacoemulsification cataract surgery at the Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund (Vien-na, Austria). The indication to perform cataract surgery will have been made prior to and in-dependently 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.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vienna Hospital Association: lead

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Cataract

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lens Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07