Pseudoexfoliation and Carpal Tunnel Study

NCT06946030 | Completed

• 1 other identifier: AnkaraTRH-FTR-NK-05
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome (CTS); Pseudoexfoliation Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Electromyography (EMG)

  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 Outcomes (1)

• Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)

  up to 12 weeks

Study Arms (3)

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

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

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (8)

• Tarim B. The role of serum biomarkers in determining systemic inflammation and cardiovascular risk in pseudoexfoliation syndrome. Int Ophthalmol. 2024 Dec 19;45(1):15. doi: 10.1007/s10792-024-03382-5.

  PMID: 39699776 BACKGROUND

• Otelea MR, Nartea R, Popescu FG, Covaleov A, Mitoiu BI, Nica AS. The Pathological Links between Adiposity and the Carpal Tunnel Syndrome. Curr Issues Mol Biol. 2022 Jun 8;44(6):2646-2663. doi: 10.3390/cimb44060181.

  PMID: 35735622 BACKGROUND

• Malakootian M, Soveizi M, Gholipour A, Oveisee M. Pathophysiology, Diagnosis, Treatment, and Genetics of Carpal Tunnel Syndrome: A Review. Cell Mol Neurobiol. 2023 Jul;43(5):1817-1831. doi: 10.1007/s10571-022-01297-2. Epub 2022 Oct 10.

  PMID: 36217059 BACKGROUND

• Shahriari M, Karimzadeh A, Esmaily H, Rezanejad S, Nikkhah H, Yadgari M, Pourhoseingholi A. Electrodiagnostic signs of carpal tunnel syndrome in ocular pseudoexfoliation syndrome. Int Ophthalmol. 2022 Sep;42(9):2749-2755. doi: 10.1007/s10792-022-02264-y. Epub 2022 Apr 27.

  PMID: 35478398 BACKGROUND

• Padhy B, Alone DP. Is pseudoexfoliation glaucoma a neurodegenerative disorder? J Biosci. 2021;46:97.

  PMID: 34785624 BACKGROUND

• Patil VR, Vallabha K, Wali K. Systemic Vascular Parameters in Ocular Pseudoexfoliation. Cureus. 2024 Jun 22;16(6):e62933. doi: 10.7759/cureus.62933. eCollection 2024 Jun.

  PMID: 39050290 BACKGROUND

• Tomczyk-Socha M, Tomczak W, Winkler-Lach W, Turno-Krecicka A. Pseudoexfoliation Syndrome-Clinical Characteristics of Most Common Cause of Secondary Glaucoma. J Clin Med. 2023 May 21;12(10):3580. doi: 10.3390/jcm12103580.

  PMID: 37240686 BACKGROUND

• Plateroti P, Plateroti AM, Abdolrahimzadeh S, Scuderi G. Pseudoexfoliation Syndrome and Pseudoexfoliation Glaucoma: A Review of the Literature with Updates on Surgical Management. J Ophthalmol. 2015;2015:370371. doi: 10.1155/2015/370371. Epub 2015 Oct 29.

  PMID: 26605078 BACKGROUND

MeSH Terms

Conditions

Exfoliation Syndrome; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine & Rehabilitation Specialist

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: May 1, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)