Analyzing eye fluid and tissues to find glaucoma-related markers in people with cataracts.

Integrated Chemical and Proteomic Analysis of Aqueous Humor and Ocular Tissues in Glaucoma and Cataract Patients

This study will test whether protein and elemental patterns in eye fluid and tissues taken during cataract surgery differ between people with primary open-angle glaucoma and those without glaucoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Military Institute od Medicine National Research Institute (other)
• Locations: 2 sites (Warsaw and 1 other locations)
• Trial ID: NCT07462000 on ClinicalTrials.gov

What this trial studies

Researchers will collect small samples of aqueous humor (~100 µL) and routinely removed ocular tissues during standard cataract surgery, with additional scleral tissue obtained in the glaucoma group. Samples will be analyzed by proteomics (LC-MS/MS) and elemental profiling (ICP-MS, with LA-ICP-MS mapping for selected samples) and interpreted using bioinformatic methods. Participants will receive routine clinical exams including intraocular pressure measurement, optic nerve evaluation, OCT retinal nerve fiber layer analysis, and Humphrey visual fields. The aim is to identify molecular and chemical patterns associated with primary open-angle glaucoma that could serve as diagnostic or prognostic biomarkers.

Who should consider this trial

Good fit: Adults (≥18) scheduled for cataract surgery are eligible, with one arm for patients who have primary open-angle glaucoma planned for combined cataract and glaucoma surgery and a control arm for cataract patients without glaucoma.

Not a fit: People with other glaucoma types, prior intraocular surgery, active or prior uveitis, advanced visual loss, pregnancy or breastfeeding, or other significant ocular disease are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could reveal biomarkers that help diagnose glaucoma earlier or predict disease progression.

How similar studies have performed: Prior proteomic and elemental analyses of aqueous humor have reported differences associated with glaucoma, but no validated clinical biomarkers have yet been established, so this approach remains exploratory.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years.
* Scheduled for cataract surgery (phacoemulsification with intraocular lens implantation).
* Ability to provide written informed consent.
* For glaucoma arm: diagnosis of primary open-angle glaucoma (POAG) with coexisting cataract, and planned combined cataract surgery with glaucoma procedure.
* For control arm: cataract without glaucoma and without other significant ocular pathology.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy or breastfeeding.
* Advanced visual impairment in the study eye (visual aquity worse than counting fingers).
* Any glaucoma type other than primary open-angle glaucoma (e.g., angle-closure, secondary, neovascular glaucoma).
* History of intraocular surgery in the study eye (including glaucoma surgery), vitreoretinal surgery, corneal transplantation, or refractive surgery.
* Active or previous uveitis.
* Other significant chronic ocular disease in the study eye (other than cataract and POAG in the glaucoma arm).
* Inability to comply with study procedures or follow-up visits.

Where this trial is running

Warsaw and 1 other locations

• Military Institute of Medicine - National Research Institute — Warsaw, Poland (RECRUITING)
• University of Warsaw — Warsaw, Poland (RECRUITING)

Study contacts

• Principal investigator: Marek Rękas, MD, PhD — Military Institute of Medicine National Research Institute
• Study coordinator: Marek Rękas, MD, PhD

Conditions: Primary Open-Angle Glaucoma, Cataract, POAG, Glaucoma, Proteomics, Aqueous Humor, LC-MS/MS, Deep Sclerectomy