Kazakh Eye Research Institute
Almaty, 050012, Kazakhstan
Location status: Recruiting
NCT Number: NCT07592988
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Almaty, 050012, Kazakhstan
Location status: Recruiting
Glaucoma is a chronic progressive optic neuropathy characterized by irreversible visual field loss. Reduction of intraocular pressure (IOP) remains the only evidence-based strategy to slow disease progression. Various treatment modalities, including laser procedures such as micropulse transscleral cyclophotocoagulation (MP-CPC) and continuous-wave cyclophotocoagulation (CPC), as well as incisional antiglaucoma surgeries, are widely used to achieve IOP control.
Inflammation is believed to play a differential role in the biological response to various glaucoma interventions. In the context of CPC and MP-CPC a controlled ("subthreshold") inflammatory response may contribute to structural and functional remodeling of the ciliary body, potentially enhancing the hypotensive effect. Interleukins present in tear fluid represent accessible, non-invasive biomarkers of ocular surface and intraocular inflammatory activity. Changes in their concentrations may reflect procedure-induced tissue response and could potentially serve as predictors of treatment efficacy.
In contrast, following incisional antiglaucoma surgeries, inflammation is more often associated with fibrotic processes, wound healing, and scar formation, which may negatively affect surgical outcomes by limiting aqueous outflow.
However, the dynamics of inflammatory mediators in the tear film following different glaucoma treatments and their relationship with IOP reduction remain insufficiently studied.
This prospective study will include patients with various types of glaucoma scheduled to undergo MP-CPC, CPC, or incisional antiglaucoma surgery. Tear samples will be collected at three time points: preoperatively (baseline), 5-7 days after treatment, and 1 month postoperatively. The concentrations of selected pro-inflammatory (IL-4, IL-6) interleukins will be measured using standardized immunoassay techniques.
Intraocular pressure will be assessed at the same time points using Corvis ST tonometry.
The primary objective of the study is to evaluate the correlation between changes in tear interleukin levels and IOP reduction at early (5-7 days) and short-term (1 month) follow-up.
Secondary objectives include:
Assessment of temporal changes in interleukin profiles after different glaucoma treatments, Comparison of inflammatory responses between MP-CPC, CPC, and surgery groups, Evaluation of the relationship between baseline interleukin levels and the degree of IOP reduction, Identification of interleukin patterns associated with a clinically significant hypotensive response, Safety evaluation, including postoperative complications and ocular surface status.
Correlation and regression analyses will be performed to determine whether baseline interleukin levels and their early postoperative changes can predict the degree and stability of IOP reduction.
The identification of inflammatory biomarkers associated with treatment response may contribute to a better understanding of the role of inflammation in glaucoma management and support the development of personalized therapeutic strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MicroPulse 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 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.
Incisional 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.
Time frame: Baseline, 5-7 days after treatment, and 1 month after treatment
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 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 treatment
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: Up to 1 month after treatment
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.
Contact information is provided by the study sponsor or research team.
Kazakh Eye Research Institute
Network
Tear Fluid Interleukin Biomarkers and Intraocular Pressure Response After Micropulse Transscleral Cyclophotocoagulation, Conventional Cyclophotocoagulation, and Antiglaucoma Surgery in Patients With Glaucoma
Acronym: TIGT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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