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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Almaty, Kazachstan, 050012
- Kazakh Eye Research Institute
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes in intraocular pressure measurements between baseline and postoperative follow-up visits
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Rate of post surgical complications
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Assiya Shaikenova, MD, Kazakh Eye Research Institute
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 193
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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