Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilitary Institute od Medicine National Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy
Procedure/SurgeryStandard-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 Implantation
Procedure/SurgeryStandard-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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Glaucoma + Cataract GroupExperimental treatment 1 intervention
Group B: Cataract Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
IOP
Intraocular Pressure
Time frame
Through study completion, an average of 1 year2
Visual Field
Visual Field of the mean defect (MD)
Time frame
Through study completion, an average of 1 year3
BCVA
Best-corrected visual acuity
Time frame
Through study completion, an average of 1 year4
Protein expression
Measured by ICP-MS/LC-MS
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Medications
Number of medications taken during the study
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov