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NCT Number: NCT07506551

Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome

Determination of proteins and their levels in the vitreous of eyes with or without pseudoexfoliation syndrome (PEX)

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This study is active but is not currently recruiting participants.

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Key information

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1140, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PEX syndrome
  • Macular pucker or macular hole and scheduled for vitrectomy
  • Age 21 or older
  • Written informed consent prior to surgery

Exclusion criteria

  • 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)

Treatment and study plan

Liquid chromatography mass spectrometry

Other

Proteomic analysis of vitreous samples of patients with epiretinal membranes or macular holes with or without pseudoexfoliation syndrome using Liquid chromatography mass spectrometry

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Prim. Prof. Dr. Oliver Findl, MBA

Other

Registry information

Official study title

Vitreous Proteomics of Patients Suffering From Pseudoexfoliation Syndrome and Epiretinal Membrane or Macular Hole: a Pilot Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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