Pseudoexfoliation SyndromeNCT06946030
Pseudoexfoliation and Carpal Tunnel Study
An observational study of Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome (CTS), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pseudoexfoliation Syndrome, Carpal Tunnel Syndrome (CTS)
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Being between the ages of 50-80
- Having been diagnosed with PES during routine eye examination
Who cannot join
- History of major hand-wrist trauma or surgical intervention
- Acromegaly
- Presence of any structural abnormality in bone structure
- Pregnancy
- Gout
- Rheumatoid arthritis
Show all 14Show fewer
- Connective tissue disease
- Acromegaly
- Thoracic outlet syndrome
- Brachial plexopathy
- Cervical disc herniation
- Presence of cardiac pacemaker
- Steroid users
- Repetitive hand operations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: 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.
Read the 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.
- Keywords
- Carpal Tunnel Syndrome (CTS), pseudoexfoliation syndrome, Biochemical marker
- Medical subject headings
- Exfoliation Syndrome, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (1)
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 May 2025
- Primary completion15 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadide Koca, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946030
- Sponsor's protocol ID
- AnkaraTRH-FTR-NK-05
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 39699776Otelea 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.
PubMed 35735622Malakootian 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.
PubMed 36217059Shahriari 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.
PubMed 35478398Padhy B, Alone DP. Is pseudoexfoliation glaucoma a neurodegenerative disorder? J Biosci. 2021;46:97.
PubMed 34785624Patil 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.
PubMed 39050290Tomczyk-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.
PubMed 37240686Plateroti 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.
PubMed 26605078
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Ocular Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06946030
- Acronym / sponsor ID
- AnkaraTRH-FTR-NK-05
- Keywords
- Carpal Tunnel Syndrome (CTS), pseudoexfoliation syndrome, Biochemical marker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Being between the ages of 50-80
- Having been diagnosed with PES during routine eye examination
Key exclusion criteria (14 listed)
- History of major hand-wrist trauma or surgical intervention
- Acromegaly
- Presence of any structural abnormality in bone structure
- Pregnancy
- Gout
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ)
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 39699776Tarim 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.
- Background: PubMed 35735622Otelea 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.
- Background: PubMed 36217059Malakootian 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.
- Background: PubMed 35478398Shahriari 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.
- Background: PubMed 34785624Padhy B, Alone DP. Is pseudoexfoliation glaucoma a neurodegenerative disorder? J Biosci. 2021;46:97.
- Background: PubMed 39050290Patil 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.
- Background: PubMed 37240686Tomczyk-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.
- Background: PubMed 26605078Plateroti 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.
- Individual participant dataSharing planned: No. 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.
Related trials for Pseudoexfoliation Syndrome
Enrolling by invitationPhase 1/2
Topical Insulin for Glaucoma (TING2)
Open Angle Glaucoma, Primary Open Angle Glaucoma
RecruitingObservational study
Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome, Cataract
Active, not recruiting
Optimal Treatment Protocol for Selective Laser Trabeculoplasty
Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma
Not yet recruitingObservational study
Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome, Cataract
Active, not recruiting
Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome
Pseudoexfoliation Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome and Carpal Tunnel Syndrome (CTS), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMG) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06946030, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.