AMD - Age-Related Macular Degeneration
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Marco Mazzola
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical success rate of pneumatic displacement | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Retinal Thickness | Baseline, 1 month, 3 months, and 6 months. | Measurement of retinal thickness (in microns) using Spectralis HRA+OCT to evaluate the anatomical response to treatment. |
Countries
Italy
Contacts
CONTACTmarco mazzola, medical doctor
CONTACTtommaso brighenti, MD
PRINCIPAL_INVESTIGATORmarco mazzola, MD
Azienda sanitaria universitaria integrata del Trentino
Outcome results
None listed