NCT06946030

Pseudoexfoliation and Carpal Tunnel Study

The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 159 (actual)
• Sponsor: Ankara Training and Research Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This prospective, single-center case-control study aimed to investigate the association between pseudoexfoliation syndrome (PES) and carpal tunnel syndrome (CTS) using biochemical markers. A total of 159 participants aged 50-80 years were categorized into PES, CTS, and control groups. Diagnoses were confirmed by slit-lamp biomicroscopy for PES and electrophysiological evaluation (EMG) for CTS. Serum biomarkers, including homocysteine, methylmalonic acid, paraoxonase-1 (PON1), homocysteine thiolactonase (HTLase), and matrix metalloproteinases (MMP-2 and MMP-9), were measured. Group comparisons, diagnostic performance (ROC analysis), and independent associations (multinomial logistic regression) were evaluated. Comorbidities were recorded and analyzed in subgroup analyses.

Detailed description

Pseudoexfoliation syndrome (PES) is a systemic disorder characterized by the accumulation of extracellular fibrillar material in ocular and extraocular tissues. It has been associated with extracellular matrix dysregulation, oxidative stress, and vascular dysfunction, and may involve systemic manifestations beyond the eye. Previous studies have suggested links between PES and several systemic conditions, including cardiovascular disease, metabolic disorders, and neurodegenerative processes. Carpal tunnel syndrome (CTS), the most common entrapment neuropathy, results from compression of the median nerve at the wrist and is influenced by both local mechanical factors and systemic conditions such as obesity, diabetes mellitus, and metabolic syndrome. Emerging evidence suggests that metabolic and inflammatory mechanisms, including dyslipidemia and oxidative stress, may contribute to peripheral nerve dysfunction. Although both PES and CTS have been associated with systemic and metabolic disturbances, the extent to which they share common pathophysiological mechanisms remains unclear. In particular, alterations in homocysteine metabolism, oxidative stress pathways, and extracellular matrix remodeling may represent overlapping biological processes. This prospective, case-control study was designed to evaluate the association between PES and CTS by comparing three groups: patients with PES, patients with CTS, and control subjects. Serum biomarkers related to homocysteine metabolism (homocysteine, methylmalonic acid), enzymatic activity (paraoxonase-1 and homocysteine thiolactonase), and extracellular matrix turnover (MMP-2 and MMP-9) were analyzed. The study also aimed to assess the coexistence of PES and CTS and to explore potential shared systemic mechanisms underlying both conditions.

Conditions

• Pseudoexfoliation Syndrome
• Carpal Tunnel Syndrome (CTS)

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-01-15
• Completion: 2026-01-30
• First posted: 2025-04-27
• Last updated: 2026-04-17

Locations

1 site across 1 country: Turkey (Türkiye)