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Recruiting NCT07462000

Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

No phase Interventional Primary Open-Angle Glaucoma (POAG) Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy, Phacoemulsification With Intraocular Lens Implantation.
Who it may be relevant to
Registry conditions: Primary Open-Angle Glaucoma (POAG), Cataract. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • IOP [Time frame: Through study completion, an average of 1 year]
  • Visual Field [Time frame: Through study completion, an average of 1 year]
  • BCVA [Time frame: Through study completion, an average of 1 year]
  • Protein expression [Time frame: Through study completion, an average of 1 year]
  • RNFL [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (1)
  • Medications [Time frame: Through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Poland · 2 centers
  • Military Institute of Medicine - National Research Institute — Warsaw
  • University of Warsaw — Warsaw

Identifiers

NCT: NCT07462000 · KB/2/26 · FBW/06/2025 · FBW/06/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗