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Pseudoexfoliation and Carpal Tunnel Study

The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06946030
Enrollment
159
Registered
2025-04-27
Start date
2025-05-01
Completion date
2026-01-30
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome (CTS), Pseudoexfoliation Syndrome

Keywords

Carpal Tunnel Syndrome (CTS), pseudoexfoliation syndrome, Biochemical marker

Brief 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.

Interventions

None listed

Sponsors

Ankara Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Being between the ages of 50-80 * Having been diagnosed with PES during routine eye examination

Exclusion criteria

* History of major hand-wrist trauma or surgical intervention * Acromegaly * Presence of any structural abnormality in bone structure * Pregnancy * Gout * Rheumatoid arthritis * Connective tissue disease * Acromegaly * Thoracic outlet syndrome * Brachial plexopathy * Cervical disc herniation * Presence of cardiac pacemaker * Steroid users * Repetitive hand operations

Design outcomes

Primary

MeasureTime frameDescription
Electromyography (EMG)up to 12 weeksElectromyography (EMG) is an examination method that measures the electrical conduction function of nerves using linear electrical current at an intensity that will not cause excessive discomfort to the patient. For this purpose, low-intensity electrical current is applied to the fingers and skin areas over the nerves, and this current is collected and measured by computerized devices from another part of the nerve or skin. Thus, it is determined whether the nerve is functioning properly.

Secondary

MeasureTime frameDescription
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)up to 12 weeksThe Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ); Boston Questionnaire Form (BQF), consists of a total of 19 questions. It includes 11 questions to assess symptom severity and 8 questions to evaluate functional capacity. Responses are multiple-choice and are scored from a minimum of one to a maximum of five points for each question. One point corresponds to the mildest symptom or best functional status, while five points correspond to the most severe symptom or worst functional status. A high average score indicates severe complaints or inadequate functional capacity. The symptom severity score is the total score obtained from 11 questions. The average symptom severity score is calculated by dividing the total score obtained from 11 questions by eleven. The functional capacity score is the total score obtained from eight questions. The average functional capacity score (AFCS) is obtained by dividing this score by eight.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026