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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Almaty, Kazachstan, 050012
- Kazakh Eye Research Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Changes in intraocular pressure measurements between baseline and postoperative follow-up visits
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rate of post surgical complications
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Assiya Shaikenova, MD, Kazakh Eye Research Institute
Studie record data
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Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 193
Plan Individuele Deelnemersgegevens (IPD)
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