- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07592988
Tear Interleukin Biomarkers After Glaucoma Treatment (TIGT)
Tear Fluid Interleukin Biomarkers and Intraocular Pressure Response After Micropulse Transscleral Cyclophotocoagulation, Conventional Cyclophotocoagulation, and Antiglaucoma Surgery in Patients With Glaucoma
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Almaty, Kasachstan, 050012
- Kazakh Eye Research Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients with ocular infection, inflammation or intraocular surgery in the study eye 2 months prior to enrollment in the study
- Albino patients that have no iris pigmentation
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: MicroPulse Transscleral Cyclophotocoagulation Group
Participants in this group will undergo MicroPulse transscleral cyclophotocoagulation for the treatment of glaucoma.
Tear samples and intraocular pressure measurements will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.
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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.
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Aktiver Komparator: Conventional Transscleral Cyclophotocoagulation Group
Participants in this group will undergo conventional continuous-wave transscleral cyclophotocoagulation for the treatment of glaucoma.
Tear samples and intraocular pressure measurements will be collected before treatment, 5-7 days after the procedure, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.
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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.
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Aktiver Komparator: Antiglaucoma Surgery Group
Participants in this group will undergo incisional antiglaucoma surgery for the treatment of glaucoma.
Tear samples and intraocular pressure measurements will be collected before surgery, 5-7 days after surgery, and 1 month postoperatively to evaluate inflammatory biomarker changes and treatment response.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction
Zeitfenster: Baseline, 5-7 days after treatment, and 1 month after treatment
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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.
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Baseline, 5-7 days after treatment, and 1 month after treatment
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment
Zeitfenster: Baseline, 5-7 days after treatment, and 1 month after treatment
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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.
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Baseline, 5-7 days after treatment, and 1 month after treatment
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Comparison of Inflammatory Response Patterns Between Treatment Groups
Zeitfenster: Baseline, 5-7 days after treatment, and 1 month after treatment
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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.
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Baseline, 5-7 days after treatment, and 1 month after treatment
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Rate of Postoperative Complications
Zeitfenster: Up to 1 month after treatment
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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.
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Up to 1 month after treatment
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Assiya Shaikenova, MD, Kazakh Eye Research Institute
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 193/2
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