Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Anatomical success rate of pneumatic displacement
研究概览
简要总结
This study investigates the prognostic value of macular neovascularization (MNV) subtypes in patients treated with pneumatic displacement for submacular hemorrhage. The researchers will compare anatomical and functional outcomes (visual acuity) between PCV, RAP, and other MNV forms within a Caucasian cohort to identify subtype-specific predictors of recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pneumatic displacement (PD) for submacular hemorrhage (SMH), secondary to macular neovascularization (MNV)
- •Age 50 years or older at the time of SMH diagnosis
- •Caucasian ethnicity
- •SMH involving the central or internal ring of the Early Treatment Diabetic Retinopathy Study (ETDRS) grid (within a 3 mm circumference centered on the fovea)
- •SMH dimensions equal to or greater than one papillary diameter
- •Pneumatic displacement treatment performed within 36 hours of SMH diagnosis
排除标准
- •SMH estimated to be present for more than 15 days at the time of diagnosis
- •SMH secondary to conditions other than MNV
- •Presence of proliferative diabetic retinopathy in the study eye
- •Aphakia in the study eye
- •Inadequate pupillary dilation, media opacities, or other impediments to retinal imaging
- •Previous pneumatic displacement procedures for SMH in the study eye
- •Ocular surgery in the 8 weeks preceding the pneumatic displacement intervention
- •Follow-up duration of less than 6 months following the procedure
研究组 & 干预措施
PCV
Patients with submacular hemorrhage secondary to Polypoidal Choroidal Vasculopathy (PCV)
RAP
Patients with submacular hemorrhage secondary to Retinal Angiomatous Proliferation (RAP), also known as Type 3 MNV
Other MNV
Patients with submacular hemorrhage secondary to other forms of Macular Neovascularization (MNV) not classified as PCV or RAP
结局指标
主要结局
Anatomical success rate of pneumatic displacement
时间窗: 5-8 days post-treatment
Percentage of patients achieving successful subretinal hemorrhage displacement, defined as the absence of subretinal blood within the internal ring of the ETDRS grid (3 mm centered on the fovea) at the first post-operative OCT
Change in Best-Corrected Visual Acuity (BCVA)
时间窗: Baseline and 6 months.
Evaluation of the difference in visual acuity from baseline to the 6-month follow-up. Snellen chart measurements will be converted to LogMAR for statistical analysis.
次要结局
- Change in Central Retinal Thickness(Baseline, 1 month, 3 months, and 6 months.)
研究者
Marco Mazzola
MEDICAL DOCTOR
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento