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Postoperative CCT in FECD vs. Non-FECD

NCT07731945 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2026-08-10

No results posted yet for this study

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. 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.

Conditions

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

Sponsors & Collaborators

  • Vienna Hospital Association

    lead OTHER_GOV

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-07-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731945 on ClinicalTrials.gov