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NCT Number: NCT07462000

Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

This observational study will compare proteomic and elemental profiles of aqueous humor and ocular tissues in patients with primary open-angle glaucoma (POAG) and cataract versus cataract controls without glaucoma. Samples collected during standard surgery will be analyzed using LC-MS/MS and ICP-MS. The goal is to identify glaucoma-associated molecular patterns with potential diagnostic or prognostic relevance.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Institute of Medicine - National Research Institute, Warsaw, Poland

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About this study

This observational study will evaluate molecular and elemental differences in aqueous humor and ocular tissues in patients with primary open-angle glaucoma (POAG) and cataract compared with cataract controls without glaucoma. Samples of aqueous humor (~100 µL) will be collected intraoperatively from the anterior chamber, and ocular tissues routinely removed during surgery (anterior lens capsule and, in the glaucoma group, scleral tissue) will be obtained for laboratory analyses.

Participants will undergo standard clinical assessment including intraocular pressure (IOP), optic nerve head evaluation, optical coherence tomography (OCT) with retinal nerve fiber layer (RNFL) analysis, and automated perimetry (Humphrey SITA Standard 24-2). Elemental profiling will be performed using ICP-MS (with LA-ICP-MS mapping in selected samples), and proteomic profiling will be conducted using LC-MS/MS with bioinformatic analysis.

The aim is to identify glaucoma-associated chemical and proteomic patterns that may serve as potential diagnostic or prognostic biomarkers and improve understanding of glaucoma pathophysiology.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy

Procedure

Standard-of-care combined cataract surgery (phacoemulsification with intraocular lens implantation) performed together with deep sclerectomy for glaucoma management. Intraoperative collection of aqueous humor and routinely removed ocular tissues (such as sclera and anterior lens capsule) is performed for research analyses.

Phacoemulsification With Intraocular Lens Implantation

Procedure

Standard-of-care cataract surgery (phacoemulsification with intraocular lens implantation). Intraoperative collection of aqueous humor and routinely removed ocular tissue (anterior lens capsule) is performed for research analyses.

Primary outcomes

  1. IOP

    Time frame: Through study completion, an average of 1 year

    Intraocular Pressure

  2. Visual Field

    Time frame: Through study completion, an average of 1 year

    Visual Field of the mean defect (MD)

  3. BCVA

    Time frame: Through study completion, an average of 1 year

    Best-corrected visual acuity

  4. Protein expression

    Time frame: Through study completion, an average of 1 year

    Measured by ICP-MS/LC-MS

  5. RNFL

    Time frame: Through study completion, an average of 1 year

    Retinal Nerve Fiber Layer (OCT)

Secondary outcomes

  1. Medications

    Time frame: Through study completion, an average of 1 year

    Number of medications taken during the study

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Rękas, MD, PhD

CONTACT

[email protected]

0048665 707 626

Wojciech Mazurek, MD

CONTACT

[email protected]

0048261 816 575

Sponsors and collaborators

Lead sponsor

Military Institute od Medicine National Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2026
Registry last updated
Mar 10, 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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