Postoperative CCT in FECD vs. Non-FECD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fuchs Endothelial Corneal Dystrophy, Cataract (Post-operative Cataract Surgery Follow-up). Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
Detailed description
This is a single-centre, prospective, controlled, non-interventional observational clinical study conducted at the Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund, Vienna, Aus-tria.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07731945 · MA15-EK26-046-0426