Tear Interleukin Biomarkers After Glaucoma Treatment
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKazakh Eye Research Institute
About this trial
This prospective study aims to evaluate inflammatory biomarkers in tear fluid in patients with glaucoma undergoing micropulse transscleral cyclophotocoagulation (MP-CPC), continuous-wave cyclophotocoagulation (CPC), and antiglaucoma surgeries. The study will assess the concentrations of pro- and anti-inflammatory interleukins in tear samples collected before treatment, 5-7 days after the procedure, and 1 month postoperatively.
Intraocular pressure (IOP) will be measured at the same time points. The correlation between changes in interleukin levels and IOP reduction will be analyzed. Additionally, the study aims to compare inflammatory response patterns among the MP-CPC, CPC, and surgical treatment groups and to identify interleukin profiles associated with a clinically significant hypotensive effect.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Decision to treat by MP-CPC Laser
Patients diagnosed with Glaucoma
Patients aged 18 years old and above
Glaucoma that is inadequately controlled on medical therapy
Disqualifiers
Patients age less than 18 years
Patients unable or unwilling to provide informed consent to participate in the study
Patients potentially unavailable for follow up visits
Patients with significant scleral thinning
Trial design
Design model
Parallel
Treatments tested in this trial
MicroPulse Transscleral Cyclophotocoagulation
Procedure/SurgeryMicroPulse transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma. The procedure will be applied transsclerally over the ciliary body using micropulse laser energy. Tear fluid samples will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.
Conventional Transscleral Cyclophotocoagulation
Procedure/SurgeryConventional continuous-wave transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma. The procedure will be applied transsclerally over the ciliary body using continuous-wave laser energy. Tear fluid samples will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.
Antiglaucoma Surgery
Procedure/SurgeryIncisional antiglaucoma surgery will be performed for the treatment of glaucoma according to the clinical indication and standard surgical protocol. Tear fluid samples will be collected before surgery, 5-7 days after surgery, and 1 month postoperatively for assessment of interleukin levels. Intraocular pressure will be measured at the same time points.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: MicroPulse Transscleral Cyclophotocoagulation GroupExperimental treatment 1 intervention
Group B: Conventional Transscleral Cyclophotocoagulation GroupActive comparator 1 intervention
Group C: Antiglaucoma Surgery GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction
This outcome will assess the association between changes in tear fluid interleukin concentrations and the reduction in intraocular pressure after glaucoma treatment. Tear fluid levels of selected interleukins, including IL-4 and IL-6, will be measured before treatment, 5-7 days after treatment, and 1 month postoperatively. Intraocular pressure will be measured at the same time points. Correlation and regression analyses will be performed to evaluate whether changes in interleukin levels are associated with the magnitude of intraocular pressure reduction.
Time frame
Baseline, 5-7 days after treatment, and 1 month after treatmentSecondary outcomes
1
Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment
This outcome will evaluate temporal changes in tear fluid interleukin concentrations after different glaucoma treatment modalities, including MicroPulse transscleral cyclophotocoagulation, conventional transscleral cyclophotocoagulation, and incisional antiglaucoma surgery. Tear fluid samples will be collected at baseline, 5-7 days after treatment, and 1 month postoperatively.
Time frame
Baseline, 5-7 days after treatment, and 1 month after treatment2
Comparison of Inflammatory Response Patterns Between Treatment Groups
This outcome will compare postoperative inflammatory biomarker patterns between the MicroPulse transscleral cyclophotocoagulation group, conventional transscleral cyclophotocoagulation group, and incisional antiglaucoma surgery group. Differences in tear fluid interleukin levels and their postoperative dynamics will be analyzed between the groups.
Time frame
Baseline, 5-7 days after treatment, and 1 month after treatment3
Rate of Postoperative Complications
This outcome will assess the rate of postoperative complications after glaucoma treatment, including hypotony, corneal edema, hyphema, iritis, vitreous hemorrhage, cystoid macular edema, ocular surface inflammation, and other procedure-related adverse events.
Time frame
Up to 1 month after treatmentSponsors and contacts
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Source ClinicalTrials.gov