Pseudoexfoliation and Carpal Tunnel Study

Ankara Training and Research Hospital

Status: Completed

Conditions: Pseudoexfoliation Syndrome; Carpal Tunnel Syndrome (CTS)

Study type: Observational

Funder types: Other

Identifiers

NCT06946030

AnkaraTRH-FTR-NK-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

118 participants in 2 patient groups

Pseudoexfoliation Group

Description:

Patients will be selected from among those diagnosed with Pseudoexfoliation Syndrome (PES). Patients who are diagnosed with PES during routine eye examination will be informed about the study, and if they agree to participate, detailed informed consent will be obtained. EMG will be performed on the same day for consenting patients to evaluate whether they have Carpal Tunnel Syndrome (CTS).

Control Group

Description:

Control group will be selected from among patients who present to physical therapy outpatient clinics with complaints such as mechanical back, knee, or hip pain, without any symptoms or findings suggestive of CTS, and matched for age and sex ratio. Patients who will constitute the control group will also be informed about the study, and detailed informed consent will be obtained from those who agree to participate. Subsequently, EMG examination will be performed on the same day to evaluate the presence of CTS.