Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

March 6, 2026 updated by: Military Institute od Medicine National Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Military Institute of Medicine - National Research Institute
        • Contact:
        • Sub-Investigator:
          • Wojciech Mazurek, MD
        • Sub-Investigator:
          • Katarzyna Lewczuk, MD, PhD
        • Sub-Investigator:
          • Joanna Jabłońska, MD, PhD
        • Sub-Investigator:
          • Barbara Rękas-Mazurek, MD
      • Warsaw, Poland
        • Recruiting
        • University of Warsaw
        • Contact:
        • Sub-Investigator:
          • Anna Ruszczyńska, PhD
        • Sub-Investigator:
          • Andrzej Gawor, PhD
        • Sub-Investigator:
          • Olha Dushna, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glaucoma + Cataract Group
Procedure: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy
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.
Active Comparator: Cataract Control Group
Procedure: Phacoemulsification With Intraocular Lens Implantation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: Through study completion, an average of 1 year
Intraocular Pressure
Through study completion, an average of 1 year
Visual Field
Time Frame: Through study completion, an average of 1 year
Visual Field of the mean defect (MD)
Through study completion, an average of 1 year
BCVA
Time Frame: Through study completion, an average of 1 year
Best-corrected visual acuity
Through study completion, an average of 1 year
Protein expression
Time Frame: Through study completion, an average of 1 year
Measured by ICP-MS/LC-MS
Through study completion, an average of 1 year
RNFL
Time Frame: Through study completion, an average of 1 year
Retinal Nerve Fiber Layer (OCT)
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medications
Time Frame: Through study completion, an average of 1 year
Number of medications taken during the study
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Institute od Medicine National Research Institute

Investigators

  • Principal Investigator: Marek Rękas, MD, PhD, Military Institute of Medicine National Research Institute
  • Principal Investigator: Ewa Bulska, PhD, University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

January 21, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/2/26
  • FBW/06/2025 (Other Grant/Funding Number: University of Warsaw)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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