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There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).
This retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcleral lutein iontophoresis |
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| Measure | Description | Time Frame |
|---|---|---|
| functional parameter | best corrected visual acuity (logMar) | August 2023 to August 2024 |
| structural parameter over the course of follow-up | Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4) | August 2023 to August 2024 |
| structural parameter over the course of follow-up | Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers) | August 2023 to August 2024 |
| structural parameter over the course of follow-up | Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers) | August 2023 to August 2024 |
| structural parameter over the course of follow-up | Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers) | August 2023 to August 2024 |
| structural parameter over the course of follow-up | changes in FAF, (descriptive - iso/hyper/hypofluorescent) | August 2023 to August 2024 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | monitoring of adverse events over the course of the follow up (n) | August 2023 to August 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| functional parameter | mean sensitivity (dB) | August 2023 to August 2024 |
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Inclusion criteria
Exclusion Criteria:
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Patients from the regions of Naples and Cagliari
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II | Naples | Italy |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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