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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Almaty、カザフスタン、050012
- Kazakh Eye Research Institute
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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.
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in intraocular pressure measurements between baseline and postoperative follow-up visits
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of post surgical complications
時間枠：Day 1, Day 3, Week 1, Week 2, Months 1
|
Rate of post surgical complications such as Hypotony, Corneal Edema, Hyphema, Iritis, Vitreous Hemorrhage and Cystoid Macular Edema
|
Day 1, Day 3, Week 1, Week 2, Months 1
|
協力者と研究者
捜査官
- 主任研究者：Assiya Shaikenova, MD、Kazakh Eye Research Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国FDA規制医薬品の研究
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