Clinical trial NCT06946030: Pseudoexfoliation and Carpal Tunnel Study
Official title: The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pseudoexfoliation Syndrome
Carpal Tunnel Syndrome (CTS)
Keywords: Carpal Tunnel Syndrome (CTS)
pseudoexfoliation syndrome
Biochemical marker
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: Investigation of the Association Between Ocular Pseudoexfoliation Syndrome (PES) and Carpal Tunnel Syndrome (CTS) with Biochemical Markers. To study the frequency of concurrent CTS and PES, and to analyze the association between PES and CTS severity.

Detailed description: Pseudoexfoliation syndrome (PES), first described by Lindberg in 1917, is a relatively common systemic disorder. While it primarily affects ocular tissue through gradual accumulation of fibrogranular material in the anterior segment of the eye, it can be observed in any other tissue. The chemical composition of the accumulated material is still not fully understood. Abnormal metabolism and overproduction of glycosaminoglycans are thought to play a key role. PES is commonly seen in males and individuals over 60 years of age, with incidence varying according to race and geographical characteristics.

This syndrome manifests itself with flaking at the pupillary margin and anterior lens capsule, increased pigmentation in the trabecular meshwork, and open-angle glaucoma. In PES, extracellular matrix deposits, exfoliative material, and amyloid accumulations have been demonstrated in other organs as well. Relationships between PES and systemic diseases such as diabetes mellitus, ischemic heart diseases, cerebrovascular diseases, and hypertension have been reported.

PES, defined as a neurodegenerative disease, has also been reported to be associated with Alzheimer's disease. It has been reported that PES affects peripheral nerves and has a direct relationship with carpal tunnel syndrome (CTS).

CTS is a condition resulting from compression of the median nerve in the carpal tunnel at the wrist and is the most common entrapment neuropathy. CTS is most commonly seen in the 3rd-5th decades and is three times more common in women than men. Most cases are idiopathic where the cause cannot be determined. While repetitive trauma is most commonly blamed in the etiology, some systemic diseases, primarily obesity, diabetes mellitus (DM), and rheumatoid arthritis (RA), are reported to play a role.

High body mass index (BMI) is an important risk factor in the development of CTS. A positive correlation between BMI and CTS severity has been reported. It has been found that CTS is more common and more severe in patients with metabolic syndrome, an endocrinopathy characterized by abdominal obesity, atherogenic dyslipidemia, high blood pressure, insulin resistance or glucose intolerance, and prothrombotic and proinflammatory states. Dyslipidemia encountered in metabolic syndrome is characterized by high triglycerides and low HDL. Dyslipidemia is reported to make a significant contribution to peripheral nerve deterioration.

Dyslipidemia has also been reported in PES patients. Although a specific pathogenesis in PES is still unknown, hypoxia, ischemia, chronic inflammation, oxidative stress, and decreased cellular defense are emphasized. In PES, increased homocysteine levels along with decreased levels of vitamin B12 and folate, which are cofactors in homocysteine metabolism, have been reported. Study results regarding the relationship between vitamin B12 and CTS are contradictory.

Our aim in this study is to investigate the frequency of co-occurrence of PES and CTS. Literature information about the association of PES and CTS is limited. The purpose of this study is to make a new evaluation on this subject and contribute to the literature. Thus, we believe we can reach data that will lay the groundwork for more comprehensive future research focused on common pathophysiology for these two syndromes whose etiopathogenesis has not been fully elucidated.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-90
* 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
* Diabetes mellitus
* Gout
* Rheumatoid arthritis
* Connective tissue disease
* Acromegaly
* Thoracic outlet syndrome
* Brachial plexopathy
* Cervical disc herniation
* Presence of cardiac pacemaker
* Steroid users
* Thyroid disease
* Repetitive hand operations

Primary outcomes:
measure: Electromyography (EMG)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
state: Altindag
Study officials:
References:
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citation: 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.
citation: 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.