Morphometric Markers of the Effectiveness of Micropulse Cyclophotocoagulation (MMEMC)
Morphometric Markers of the Effectiveness of Micropulse Cyclophotocoagulation: The Influence of Choroidal Thickness on the Extent and Duration of the Hypotensive Effect
This prospective study aims to evaluate morphometric markers of treatment response following micropulse transscleral cyclophotocoagulation (MP-CPC) in patients with glaucoma. The study will assess changes in choroidal thickness and the choroidal vascularity index (CVI) measured by optical coherence tomography (OCT) before treatment, 3-7 days after the procedure, and 1 month postoperatively.
Intraocular pressure (IOP) will be measured at the same time points. The correlation between changes in choroidal thickness, the choroidal vascularity index (CVI) and IOP reduction will be analyzed. Additionally, the study seeks to determine the minimal baseline choroidal thickness associated with a clinically significant hypotensive effect after MP-CPC.
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. Micropulse transscleral cyclophotocoagulation (MP-CPC) has become an increasingly used laser modality due to its favorable safety profile compared to continuous-wave cyclophotocoagulation.
Despite demonstrated efficacy, the magnitude and durability of the hypotensive effect after MP-CPC vary considerably among patients. Identification of structural ocular biomarkers associated with treatment response may improve patient selection and enable a more individualized therapeutic approach.
The choroid plays a key role in ocular blood flow regulation and may influence aqueous humor dynamics, particularly uveoscleral outflow. Variations in choroidal thickness may reflect differences in vascular reactivity, tissue compliance, and structural characteristics that could modulate the biological response to laser energy.
This prospective study will include patients with various types of glaucoma scheduled to undergo MP-CPC. Subfoveal choroidal thickness and the choroidal vascularity index (CVI) will be measured using enhanced depth imaging optical coherence tomography (EDI-OCT) at three time points: Preoperatively (baseline), 3-7 days after MP-CPC, 1 month after MP-CPC 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 choroidal thickness, the choroidal vascularity index (CVI) and IOP reduction at early (3-7 days) and short-term (1 month) follow-up.
Secondary objectives include: Assessment of dynamic changes in choroidal thickness after MP-CPC, Evaluation of the relationship between baseline choroidal thickness and the degree of IOP reduction, Determination of a threshold (minimal) baseline choroidal thickness associated with a clinically significant hypotensive response, Safety evaluation, including changes in visual acuity and postoperative complications Correlation and regression analyses will be performed to determine whether baseline choroidal thickness and its early postoperative changes can predict the degree and stability of IOP reduction.
The identification of morphometric predictors of MP-CPC efficacy may contribute to the development of personalized treatment algorithms and improve prognostic stratification in patients undergoing laser management of glaucoma.
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 glaucoma.
The procedure will be performed using a laser power of 2500 mW, with a treatment duration of 100-120 seconds per hemifield and 5-6 sweeps per hemifield.
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MicroPulse transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma.
Laser treatment will be applied transsclerally over the ciliary body using a power of 2500 mW.
The treatment duration will be 100-120 seconds per hemifield, with 5-6 sweeps per hemifield.
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실험적: Conventional transscleral cyclophotocoagulation group
Participants in this group will undergo conventional transscleral cyclophotocoagulation for glaucoma.
The procedure will be performed using a laser power of 1.4-2.3
W, with an exposure duration of 1.4-1.8
seconds per coagulation spot.
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Conventional transscleral cyclophotocoagulation will be performed as a laser procedure for the treatment of glaucoma.
Laser treatment will be applied transsclerally over the ciliary body using a power of 1.4-2.3
W, with an exposure duration of 1.4-1.8
seconds per coagulation spot.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in intraocular pressure measurements between baseline and postoperative follow-up visits
기간: Day 1, Day 3, Week 1, Week 2, Month 1
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Baseline (pre-operative condition) and post operative intraocular pressure will be measured
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Day 1, Day 3, Week 1, Week 2, Month 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of post surgical complications
기간: Day 1, Day 3, Week 1, Week 2, Months 1
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Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema
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Day 1, Day 3, Week 1, Week 2, Months 1
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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
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