Cataract, Primary Open-Angle Glaucoma (POAG)
Conditions
Keywords
POAG, Glaucoma, Cataract, Primary Open-Angle Glaucoma, Proteomics, Aqueous Humor, LC-MS/MS, Deep Sclerectomy
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.
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
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.
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.
Sponsors
Military Institute od Medicine National Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | Through study completion, an average of 1 year | Intraocular Pressure |
| Visual Field | Through study completion, an average of 1 year | Visual Field of the mean defect (MD) |
| BCVA | Through study completion, an average of 1 year | Best-corrected visual acuity |
| Protein expression | Through study completion, an average of 1 year | Measured by ICP-MS/LC-MS |
| RNFL | Through study completion, an average of 1 year | Retinal Nerve Fiber Layer (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medications | Through study completion, an average of 1 year | Number of medications taken during the study |
Countries
Poland
Contacts
CONTACTMarek Rękas, MD, PhD
CONTACTWojciech Mazurek, MD
PRINCIPAL_INVESTIGATORMarek Rękas, MD, PhD
Military Institute of Medicine National Research Institute
PRINCIPAL_INVESTIGATOREwa Bulska, PhD
University of Warsaw
Outcome results
None listed