Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

NCT07462000 | Recruiting

• 2 other identifiers: KB/2/26FBW/06/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary Open-Angle Glaucoma (POAG); Cataract

Keywords

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

Outcome Measures

Primary Outcomes (5)

• IOP

  Intraocular Pressure

  Through study completion, an average of 1 year

• Visual Field

  Visual Field of the mean defect (MD)

  Through study completion, an average of 1 year

• BCVA

  Best-corrected visual acuity

  Through study completion, an average of 1 year

• Protein expression

  Measured by ICP-MS/LC-MS

  Through study completion, an average of 1 year

• RNFL

  Retinal Nerve Fiber Layer (OCT)

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Medications

  Through study completion, an average of 1 year

Study Arms (2)

Glaucoma + Cataract Group

EXPERIMENTAL

Procedure: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy

Cataract Control Group

ACTIVE COMPARATOR

Procedure: Phacoemulsification With Intraocular Lens Implantation

Interventions

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.

Cataract Control Group

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.

Glaucoma + Cataract Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Military Institute od Medicine National Research Institute: lead

Study Sites (2)

Military Institute of Medicine - National Research Institute

Warsaw, Poland

RECRUITING

University of Warsaw

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Cataract; Glaucoma

Interventions

Phacoemulsification; Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Marek Rękas, MD, PhD

  Military Institute of Medicine National Research Institute

  PRINCIPAL INVESTIGATOR

• Ewa Bulska, PhD

  University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Rękas, MD, PhD

CONTACT

0048665 707 626; mrekas@wim.mil.pl

Wojciech Mazurek, MD

CONTACT

0048261 816 575; wmazurek@wim.mil.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 10, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): January 21, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)