NCT07462000

Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Military Institute od Medicine National Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-21
• Primary completion: 2027-01-21
• Completion: 2027-11-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

2 sites across 1 country: Poland