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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 主要终点
- Central corneal thickness (CCT, µm) six weeks after routine phacoemulsification cataract surgery, compared between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT
研究概览
简要总结
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:
- Preoperative baseline visit (routine cataract work-up)
- 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.
详细描述
This is a single-centre, prospective, controlled, non-interventional observational clinical study conducted at the Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund, Vienna, Austria.
Fuchs endothelial corneal dystrophy (FECD) is a progressive disorder of the corneal endothelium characterized clinically by central guttae and a gradual loss of endothelial barrier and pump function, ultimately leading to corneal edema, increased corneal thickness, and visual impairment. In FECD, thickening is primarily a consequence of stromal hydration (deturgescence failure), and corneal edema can be present even when it is not yet obvious on slit-lamp examination ("subclinical edema"), which complicates clinical staging and risk estimation in routine practice.
Because cataract prevalence increases with age, cataract and FECD frequently coexist, and cataract surgery planning in FECD must account for the reduced endothelial reserve. Phacoemulsification - although highly standardized and effective - exerts mechanical, ultrasonic, and fluidic stress on the endothelium and can cause postoperative endothelial cell loss even in otherwise healthy eyes. Large, randomized data have shown that modern cataract surgery can measurably affect the corneal endothelium and that the magnitude of endothelial impact depends on patient- and surgery-related factors. Clinically, inadequate endothelial pump function is a key mechanism underlying postoperative corneal edema after cataract surgery, making endothelial vulnerability a central safety consideration in FECD eyes.
Central corneal thickness (CCT) is a routinely available, quantitative parameter that reflects corneal hydration status and is commonly used in clinical decision making in FECD, because the central cornea thickens as edema develops. In FECD specifically, clinicians frequently incorporate CCT into perioperative assessment; however, isolated CCT values have limitations because normal corneas can occasionally be thick and because "pre-edematous" baseline thickness varies across individuals. As a result, thresholds (e.g., around 640 µm) have been proposed as practical indicators of clinically relevant edema in FECD, but the overlap between normal variation and early/subclinical disease underscores the need to interpret CCT in context and - when possible - relative to baseline.
In the postoperative setting, transient corneal swelling (reflected by increased CCT) is a well-recognized phenomenon after phacoemulsification, and it is mechanistically linked to surgical endothelial stress. Studies evaluating postoperative corneal swelling after phacoemulsification show that CCT can increase early after surgery and then trend back toward baseline in uncomplicated cases, whereas persistent edema is more likely when endothelial reserve is compromised. Moreover, postoperative corneal swelling has been shown to correlate with endothelial cell loss after phacoemulsification, supporting the use of CCT as a clinically meaningful, non-invasive outcome reflecting endothelial "load" in the early postoperative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Corneal scars
- •Pseudoexfoliation (PEX) syndrome
- •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
研究组 & 干预措施
Non-FECD
Patients without Fuchs endothelial corneal dystrophy (FECD). Control cohort: No clinical evidence of corneal endothelial disease at baseline (no signs consistent with FECD or other endothelial pathology)
Patients with Fuchs endothelial corneal dystrophy (FECD)
Patients with Fuchs endothelial corneal dystrophy (FECD). Clinical diagnosis of FECD based on slit-lamp findings, graded according to Krachmer et al. (1978).
结局指标
主要结局
Central corneal thickness (CCT, µm) six weeks after routine phacoemulsification cataract surgery, compared between FECD and non-FECD eyes, adjusting for baseline (preoperative) CCT
时间窗: 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.
次要结局
未报告次要终点
