Primary Open-Angle Glaucoma (POAG)NCT07462000
Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract
A study testing Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy and Phacoemulsification With Intraocular Lens Implantation in people with Primary Open-Angle Glaucoma (POAG) and Cataract, run by Military Institute od Medicine National Research Institute at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open-Angle Glaucoma (POAG), Cataract
- What is being tested?
- Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy and Phacoemulsification With Intraocular Lens Implantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPoland
- Study dates
- 21 Jan 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Military Institute of Medicine - National Research Institute
Warsaw
Marek Rękas, MD, PhD, 0048665 707 626, mrekas@wim.mil.pl
Wojciech Mazurek, MD
- Recruiting
University of Warsaw
Warsaw
Ewa Bulska, PhD, 0048604 119 870, ebulska@chem.uw.edu.pl
Anna Ruszczyńska, PhD
About this study
Official title: 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.
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.
- Conditions
- Primary Open-Angle Glaucoma (POAG), Cataract
- Being tested
- Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy, Phacoemulsification With Intraocular Lens Implantation
- Keywords
- POAG, Glaucoma, Cataract, Primary Open-Angle Glaucoma, Proteomics, Aqueous Humor, LC-MS/MS, Deep Sclerectomy
- Medical subject headings
- Glaucoma, Open-Angle, Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification With Intraocular Lens Implantation and Deep SclerectomyProcedure or surgery
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 ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma + Cataract Group | Experimental | Not described Receives: Procedure: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy |
| Cataract Control Group | Active comparator | Not described Receives: Procedure: Phacoemulsification With Intraocular Lens Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular Pressure
Measured: Through study completion, an average of 1 year
Visual Field
Visual Field of the mean defect (MD)
Measured: Through study completion, an average of 1 year
BCVA
Best-corrected visual acuity
Measured: Through study completion, an average of 1 year
Protein expression
Measured by ICP-MS/LC-MS
Measured: Through study completion, an average of 1 year
RNFL
Retinal Nerve Fiber Layer (OCT)
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Medications
Number of medications taken during the study
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start21 Jan 2026
- Primary completion21 Jan 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-Angle Glaucoma (POAG)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group design comparing patients with glaucoma and cataract to cataract-only controls. Biological samples are collected intraoperatively during standard-of-care surgery for laboratory analysis.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marek Rękas, MD, PhD, Principal investigator, Military Institute od Medicine National Research InstituteEwa Bulska, PhD, Principal investigator, University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462000
- Sponsor's protocol ID
- KB/2/26
- Other IDs
- FBW/06/2025, FBW/06/2025
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Chemical and Proteomic Analysis of Aqueous Humor and Ocular Tissues in Glaucoma and Cataract Patients
- ClinicalTrials.gov ID
- NCT07462000
- Acronym / sponsor ID
- KB/2/26
- Conditions
- Primary Open-Angle Glaucoma (POAG), Cataract
- Keywords
- POAG, Glaucoma, Cataract, Primary Open-Angle Glaucoma, Proteomics, Aqueous Humor, LC-MS/MS, Deep Sclerectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group design comparing patients with glaucoma and cataract to cataract-only controls. Biological samples are collected intraoperatively during standard-of-care surgery for laboratory analysis.
| Arm | Type | Receives |
|---|---|---|
| Glaucoma + Cataract Group | Experimental | Procedure: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy |
| Cataract Control Group | Active comparator | Procedure: Phacoemulsification With Intraocular Lens Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification With Intraocular Lens Implantation and Deep SclerectomyStandard-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 or surgery | Glaucoma + Cataract Group |
| Phacoemulsification With Intraocular Lens ImplantationStandard-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. | Procedure or surgery | Cataract Control Group |
Primary outcome
IOP
Time frame: Through study completion, an average of 1 year
Intraocular Pressure
Visual Field
Time frame: Through study completion, an average of 1 year
Visual Field of the mean defect (MD)
BCVA
Time frame: Through study completion, an average of 1 year
Best-corrected visual acuity
Protein expression
Time frame: Through study completion, an average of 1 year
Measured by ICP-MS/LC-MS
RNFL
Time frame: Through study completion, an average of 1 year
Retinal Nerve Fiber Layer (OCT)
1 secondary outcome
Medications
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Open-Angle Glaucoma (POAG)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marek Rękas, MD, PhD principal investigator
Military Institute od Medicine National Research Institute
Ewa Bulska, PhD principal investigator
University of Warsaw
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy and Phacoemulsification With Intraocular Lens Implantation in people with Primary Open-Angle Glaucoma (POAG) and Cataract, run by Military Institute od Medicine National Research Institute at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Rękas, MD, PhD (0048665 707 626, mrekas@wim.mil.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.