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Postoperative CCT in FECD vs. Non-FECD

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Study description expanded, about 646 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07731945
Lead Sponsor Vienna Hospital Association
Conditions
(from sponsor)		 Fuchs Endothelial Corneal Dystrophy, Cataract (Post-operative Cataract Surgery Follow-up)
Related terms Cataract, Fuchs' Endothelial Dystrophy
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov