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RecruitingNCT07462000Updated Mar 10, 2026

Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

An interventional study of Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy and Phacoemulsification With Intraocular Lens Implantation in Primary Open-Angle Glaucoma (POAG) and Cataract, sponsored by Military Institute od Medicine National Research Institute. Recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.

Sponsored by Military Institute od Medicine National Research Institute · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Primary Open-Angle Glaucoma (POAG)
  • Cataract

Keywords

  • POAG
  • Glaucoma
  • Cataract
  • Primary Open-Angle Glaucoma
  • Proteomics
  • Aqueous Humor
  • LC-MS/MS
  • Deep Sclerectomy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Glaucoma + Cataract Group

    Procedure: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy

  • Active comparator
    Cataract Control Group

    Procedure: Phacoemulsification With Intraocular Lens Implantation

Interventions

  • ProcedurePhacoemulsification 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.

  • ProcedurePhacoemulsification 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.

05

What researchers measure

Primary outcomes

  1. IOP

    Intraocular Pressure

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

  2. Visual Field

    Visual Field of the mean defect (MD)

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

  3. BCVA

    Best-corrected visual acuity

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

  4. Protein expression

    Measured by ICP-MS/LC-MS

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

  5. RNFL

    Retinal Nerve Fiber Layer (OCT)

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

Secondary outcomes

  1. Medications

    Number of medications taken during the study

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

06

Study locations

2 of 2 sites recruiting
  • Military Institute of Medicine - National Research Institute
    Warsaw, Poland
    • Marek Rękas, MD, PhD · Contact · mrekas@wim.mil.pl · 0048665 707 626
    • Wojciech Mazurek, MD · Sub investigator
    • Katarzyna Lewczuk, MD, PhD · Sub investigator
    • Joanna Jabłońska, MD, PhD · Sub investigator
    • Barbara Rękas-Mazurek, MD · Sub investigator
    Recruiting
  • University of Warsaw
    Warsaw, Poland
    • Ewa Bulska, PhD · Contact · ebulska@chem.uw.edu.pl · 0048604 119 870
    • Anna Ruszczyńska, PhD · Sub investigator
    • Andrzej Gawor, PhD · Sub investigator
    • Olha Dushna, PhD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07462000
Lead sponsor
Military Institute od Medicine National Research Institute
Responsible party
Sponsor
First posted
Mar 10, 2026
Start date
Jan 21, 2026
Primary completion
Jan 21, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Mar 10, 2026

Study contacts

Marek Rękas, MD, PhD
Contact
mrekas@wim.mil.pl
0048665 707 626
Wojciech Mazurek, MD
Contact
wmazurek@wim.mil.pl
0048261 816 575
Marek Rękas, MD, PhD
principal investigator · Military Institute od Medicine National Research Institute
Ewa Bulska, PhD
principal investigator · University of Warsaw

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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