Pseudoexfoliation SyndromeNCT07506551
Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome
A study testing Liquid chromatography mass spectrometry in people with Pseudoexfoliation Syndrome, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Determination of proteins and their levels in the vitreous of eyes with or without pseudoexfoliation syndrome (PEX) Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Pseudoexfoliation Syndrome
- What is being tested?
- Liquid chromatography mass spectrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jul 2023to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PEX syndrome
- Macular pucker or macular hole and scheduled for vitrectomy
- Age 21 or older
- Written informed consent prior to surgery
Who cannot join
- Previous vitrectomy or intravitreal application of drugs
- Systemic anti-inflammatory drugs
- Pre- surgical topical anti-inflammatory drugs (NSAR, Steroids)
- Pre- surgical topical prostaglandins
- Diabetic retinopathy
- AMD
- PEX Syndrome only in the contralateral eye (the eye not scheduled for surgery)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
About this study
Official title: Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome and Epiretinal Membrane or Macular Hole: a Pilot Study
Determination of proteins and their levels in the vitreous of eyes with or without pseudoexfoliation syndrome (PEX)
Read the detailed description
Pseudoexfoliation syndrome (PEX) is a systemic disorder that leads to the deposition of extracellular material in various tissues, particularly in the anterior segment of the eye. This material consists mainly of elastic microfibrils. PEX is believed to be an age-related condition whose incidence and prevalence vary by region but increase in patients over 50 years of age. Due to demographic changes, the number of PEX patients is expected to rise, making it important to understand this condition, its pathogenesis, and its complications.
The pathogenesis of PEX syndrome has not yet been fully elucidated. The interplay of growth factors, oxidative stress, inflammation, and cellular damage is described as a key factor in the development of the disease. Detailed immunohistochemical and biochemical studies have shown that several proteins are heavily involved in the pathogenesis of PEX.
The anterior segment of the eye is frequently affected by PEX, where the PEX material is present in the aqueous humor, and its accumulation leads to visible deposits on the anterior lens capsule, the edge of the pupil, or the anterior chamber angle. Several proteomics studies of the aqueous humor have been conducted, demonstrating that oxidative stress and inflammation contribute to the development of PEX. However, there is a lack of studies on PEX and its effects on the posterior segment. Some studies suggest that the posterior segment is primarily affected. Interestingly, PEX has recently been linked to diseases/pathologies of the vitreoretinal interface (VRI). It has been shown that the rates of posterior vitreous detachment (PVD) and epiretinal membranes (ERM) are higher in eyes with PEX.
The pathogenesis of ERM is not fully understood, but similar to PEX, inflammation, inflammatory proteins, and cytokines appear to play an important role in the development of ERM.
To further investigate the differences in proteins and their levels in the vitreous humor of PEX and non-PEX eyes, the aim of the study is to perform a non-targeted proteomic analysis using liquid chromatography coupled with mass spectrometry (LC-MS) of the vitreous humor from PEX eyes with ERM, compared to vitreous humor without PEX but with ERM.
- Conditions
- Pseudoexfoliation Syndrome
- Being tested
- Liquid chromatography mass spectrometry
- Keywords
- pseudoexfoliation syndrome, vitreous, proteomics
- Medical subject headings
- Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid chromatography mass spectrometryOther
Proteomic analysis of vitreous samples of patients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome using Liquid chromatography mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for vitrectomy | Other | Patients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome Receives: Other: Liquid chromatography mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein levels
Protein levels in vitreous samples of patients with and without pseudoexfoliation syndrome will be measured using Liquid chromatography mass spectrometry
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start6 Jul 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prim. Univ. Prof. Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery (VIROS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506551
- Sponsor's protocol ID
- PEX Proteomics
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome and Epiretinal Membrane or Macular Hole: a Pilot Study
- ClinicalTrials.gov ID
- NCT07506551
- Acronym / sponsor ID
- PEX Proteomics
- Conditions
- Pseudoexfoliation Syndrome
- Keywords
- pseudoexfoliation syndrome, vitreous, proteomics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Apr 2026 (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.
Determination of proteins and their levels in the vitreous of eyes with or without pseudoexfoliation syndrome (PEX)
Detailed description
Pseudoexfoliation syndrome (PEX) is a systemic disorder that leads to the deposition of extracellular material in various tissues, particularly in the anterior segment of the eye. This material consists mainly of elastic microfibrils. PEX is believed to be an age-related condition whose incidence and prevalence vary by region but increase in patients over 50 years of age. Due to demographic changes, the number of PEX patients is expected to rise, making it important to understand this condition, its pathogenesis, and its complications.
The pathogenesis of PEX syndrome has not yet been fully elucidated. The interplay of growth factors, oxidative stress, inflammation, and cellular damage is described as a key factor in the development of the disease. Detailed immunohistochemical and biochemical studies have shown that several proteins are heavily involved in the pathogenesis of PEX.
The anterior segment of the eye is frequently affected by PEX, where the PEX material is present in the aqueous humor, and its accumulation leads to visible deposits on the anterior lens capsule, the edge of the pupil, or the anterior chamber angle. Several proteomics studies of the aqueous humor have been conducted, demonstrating that oxidative stress and inflammation contribute to the development of PEX. However, there is a lack of studies on PEX and its effects on the posterior segment. Some studies suggest that the posterior segment is primarily affected. Interestingly, PEX has recently been linked to diseases/pathologies of the vitreoretinal interface (VRI). It has been shown that the rates of posterior vitreous detachment (PVD) and epiretinal membranes (ERM) are higher in eyes with PEX.
The pathogenesis of ERM is not fully understood, but similar to PEX, inflammation, inflammatory proteins, and cytokines appear to play an important role in the development of ERM.
To further investigate the differences in proteins and their levels in the vitreous humor of PEX and non-PEX eyes, the aim of the study is to perform a non-targeted proteomic analysis using liquid chromatography coupled with mass spectrometry (LC-MS) of the vitreous humor from PEX eyes with ERM, compared to vitreous humor without PEX but with ERM.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for vitrectomy | Other | Other: Liquid chromatography mass spectrometryPatients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PEX syndrome
- Macular pucker or macular hole and scheduled for vitrectomy
- Age 21 or older
- Written informed consent prior to surgery
Key exclusion criteria (7 listed)
- Previous vitrectomy or intravitreal application of drugs
- Systemic anti-inflammatory drugs
- Pre- surgical topical anti-inflammatory drugs (NSAR, Steroids)
- Pre- surgical topical prostaglandins
- Diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid chromatography mass spectrometryProteomic analysis of vitreous samples of patients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome using Liquid chromatography mass spectrometry | Other | Patients scheduled for vitrectomy |
Primary outcome
Protein levels
Time frame: 24 months
Protein levels in vitreous samples of patients with and without pseudoexfoliation syndrome will be measured using Liquid chromatography mass spectrometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pseudoexfoliation Syndrome
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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.
Oliver Findl, Prim. Univ. Prof. Dr. principal investigator
Vienna Institute for Research in Ocular Surgery (VIROS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid chromatography mass spectrometry in people with Pseudoexfoliation Syndrome, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
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?
Protein levels (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.