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Selecting Fuchs patients for drug trials involving endothelial cell proliferation
Thomas R Shearer1, Winston D Chamberlain2, Atsuko Fujii1,3
1Department of Integrative Biosciences, Oregon Health & Science University, `Portland, OR - USA.
Purpose:
Fuchs endothelial corneal dystrophy (FECD) might be managed by drug treatment before becoming severe enough to require surgery. For a clinical trial of such a drug, we hypothesize that selecting an adequate number of patients with FECD with only moderately compromised cell densities will be challenging. Thus, the purpose of the present study was to measure the prevalence of patients with FECD exhibiting moderately decreased corneal cell densities.
Methods:
A retrospective data mining study (cross-sectional study) was performed on patient charts presenting at a large US northwestern academic health center by searching for diagnosis ICD-9 code 371.57 and Fuchs corneal dystrophies, including those with prior cataract surgeries and/or existing glaucoma. Patients with prior corneal transplants were excluded. Noncontact specular photomicroscopic data (Topcon 2000) were obtained from the central region whenever possible, and individual eyes were grouped according to cell density (cells/mm2): severe (<800), moderate (800-1,500), and mild (>1,500).
Results:
The values for 98 eyes from 61 patients with FECD were as follows (mean ± SD): corneal thickness 573 ± 59 μm, cell size 627 ± 336 μm2/cell, coefficient of variation 23 ± 7, and density 1,883 ± 703 cells/mm2. The moderate subgroup with cell density values averaging 1,184 ± 212 (26) comprised 27% of the total FECD patient pool.
Conclusions:
Only approximately 1 out of 4 patients with FECD will show moderately compromised corneal cell densities. A moderate level of damage may be optimal for clinical trials for testing topical drugs on endothelial cell viability. Thus, investigators will need to initially screen a fourfold excess of all patients with FECD.
Insights
Finding patients with moderately affected Fuchs endothelial corneal dystrophy (FECD) for drug trials is challenging. Only about 27% of FECD patients have this moderate cell density, requiring extensive screening.
Area of Science:
- Ophthalmology
- Corneal Diseases
- Cell Biology
Background:
- Fuchs endothelial corneal dystrophy (FECD) is a progressive condition affecting corneal clarity.
- Early-stage drug interventions are being explored to manage FECD before surgical intervention.
- Identifying patients with specific disease severity is crucial for clinical trial efficacy.
Purpose of the Study:
- To determine the prevalence of patients with FECD exhibiting moderately decreased corneal cell densities.
- To assess the feasibility of recruiting patients for clinical trials targeting early-stage FECD.
Main Methods:
- Retrospective cross-sectional study of patient charts at a US academic health center.
- Inclusion of patients with FECD, excluding those with prior corneal transplants.
- Analysis of specular photomicroscopy data to categorize corneal cell densities (severe, moderate, mild).
Main Results:
- Data from 98 eyes of 61 FECD patients were analyzed.
- The moderate cell density subgroup (800-1,500 cells/mm²) represented 27% of the study population.
- Average cell density in the moderate group was 1,184 ± 212 cells/mm².
Conclusions:
- A significant majority of FECD patients do not present with moderate corneal cell compromise.
- Screening approximately four times the required number of FECD patients is necessary for clinical trials.
- Targeting moderate disease stages may be optimal for evaluating topical drug efficacy in FECD.
