Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• IOP [Срок оценки: Through study completion, an average of 1 year]
• Visual Field [Срок оценки: Through study completion, an average of 1 year]
• BCVA [Срок оценки: Through study completion, an average of 1 year]
• Protein expression [Срок оценки: Through study completion, an average of 1 year]
• RNFL [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (1)

• Medications [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Польша · 2 центра

• Military Institute of Medicine - National Research Institute — Warsaw
• University of Warsaw — Warsaw

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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