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The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are:
Treatment consists in two cycles with two phases each:
Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks).
Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks). |
|
| Sham group | Sham Comparator | Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy) | Device | Each session consists of:
Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity variation | ETDRS letters | 1 month, 2 months and 4 months after each cycle |
| Drusen Volume Variation | Based on SD-OCT Heidelberg | 1 month, 2 months and 4 months after each cycle |
| Contrast sensitivity variation | Based on Pelli Robson chart | 1 month, 2 months and 4 months after each cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Giannaccare | Contact | 003909613647135 | giuseppe.giannaccare@unicz.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Paris | Recruiting | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39271642 | Derived | Borrelli E, Coco G, Pellegrini M, Mura M, Ciarmatori N, Scorcia V, Carnevali A, Lucisano A, Borselli M, Rossi C, Reibaldi M, Ricardi F, Vagge A, Nicolo M, Forte P, Cartabellotta A, Hasanreisoglu M, Kesim C, Demirel S, Yanik O, Bernabei F, Rothschild PR, Farrant S, Giannaccare G. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Nov;13(11):2855-2868. doi: 10.1007/s40123-024-01030-w. Epub 2024 Sep 13. |
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| Sham Mask | Device | Low light emission mask (Sham Mask, Espansione group, Bologna, Italy) |
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| Università degli Studi di Ferrara | Recruiting | Ferrara | Italy |
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| Università degli studi della Campania Luigi Vanvitelli | Recruiting | Naples | Italy |
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| Università di Torino | Recruiting | Torino | Italy |
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| University of Ankara | Recruiting | Ankara | Turkey (Türkiye) |
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| Koç University Hospital | Recruiting | Koç | Turkey (Türkiye) |
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| Earlam and Christopher | Recruiting | Taunton | United Kingdom |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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