- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Almaty, 카자흐스탄, 050012
- Kazakh Eye Research Institute
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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.
|
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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Association Between Changes in Tear Fluid Interleukin Levels and Intraocular Pressure Reduction
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Tear Fluid Interleukin Concentrations After Glaucoma Treatment
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Assiya Shaikenova, MD, Kazakh Eye Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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