Recruiting NCT07427160
Prognostic Role of Macular Neovascular Membrane Subtype in Pneumatic Displacement of Macular Hemorrhages
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AMD - Age-Related Macular Degeneration. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Anatomical success rate of pneumatic displacement [Time frame: 5-8 days post-treatment]
- Change in Best-Corrected Visual Acuity (BCVA) [Time frame: Baseline and 6 months.]
Secondary outcome measures (1)
- Change in Central Retinal Thickness [Time frame: Baseline, 1 month, 3 months, and 6 months.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Ospedale Santa Chiara Di Trento — Trento
Identifiers
NCT: NCT07427160 · GAS.MNV