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Completed

NCT Number: NCT06946030

Pseudoexfoliation and Carpal Tunnel Study

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Electromyography (EMG)

    Time frame: up to 12 weeks

    Electromyography (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 outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

    Time frame: up to 12 weeks

    The 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.

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Official study title

The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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