Pseudoexfoliation and Carpal Tunnel Study

April 15, 2026 updated by: Nadide Koca, Ankara Training and Research Hospital

The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Altindag
      • Ankara, Altindag, Turkey (Türkiye), 06230
        • Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Case group participants will be selected from patients diagnosed with PES during eye examination. After informed consent, EMG will be performed to evaluate for CTS. Boston CTS Questionnaire will assess symptom severity in CTS-positive patients. Demographics, comorbidities, EMG and questionnaire results will be recorded. Control group will consist of age/gender-matched patients with mechanical back, knee, or hip pain without CTS symptoms. They will also undergo EMG after consent. All demographic data, comorbidities, and EMG results will be documented for both groups.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pseudoexfoliation Group
Patients diagnosed with pseudoexfoliation syndrome (PES) during routine ophthalmological examination. All participants underwent electrophysiological evaluation (EMG) to assess the presence of CTS.
Control Group
The control group consisted of symptomatic individuals presenting to physical therapy outpatient clinics with complaints such as mechanical back, knee, or hip pain. Participants had no electrophysiological evidence of carpal tunnel syndrome (CTS) and were matched for age and sex. All individuals underwent electrophysiological evaluation (EMG).
Carpal Tunnel Syndrome Group
Patients with electrophysiologically confirmed carpal tunnel syndrome (CTS). All participants underwent nerve conduction studies (EMG), and only those meeting diagnostic criteria for CTS were included in this group. Clinical symptom severity was assessed using the Boston Carpal Tunnel Questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraTRH-FTR-NK-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The collected individual patient data contains sensitive personal health information protected by privacy regulations. Due to ethical considerations and patient confidentiality requirements specified in our informed consent protocol, we are unable to share the raw individual patient data with other researchers. However, aggregated and anonymized statistical results will be made available through scientific publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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