Boyer, David; Hu, Allen; Warrow, David; Xavier, Samantha; Gonzalez, Victor; Lad, Eleonora; Rosen, Richard B; Do, Diana; Schneiderman, Todd; Hu, Allen; Munk, Marion R; Jaffe, Glenn; Tedford, Stephanie E; Croissant, Cindy L; Walker, Michael; Rückert, Rene; Tedford, Clark E (2024). LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the LumiThera Valeda Light Delivery System. Retina, 44(3), pp. 487-497. Wolters Kluwer 10.1097/IAE.0000000000003980
|
Text
lightsite_iii__13_month_efficacy_and_safety.521.pdf - Published Version Available under License Creative Commons: Attribution-Noncommercial-No Derivative Works (CC-BY-NC-ND). Download (1MB) | Preview |
PURPOSE
The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) AMD using the LumiThera Valeda® Light Delivery System.
METHODS
LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were treated with multiwavelength PBM (590, 660 and 850 nm) or Sham treatment delivered 9 treatments over 3-5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report.
RESULTS
A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy BCVA endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 - -0.1, p = 0.02)(PBM alone: 5.4 letters (SE 0.96), CI: 3.5 - 7.3, p < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7 - 5.2, p < 0.0001). The PBM group showed a significant decrease in new onset GA (p = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed.
CONCLUSIONS
LIGHTSITE III provides a prospective, randomized controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Ophthalmology |
UniBE Contributor: |
Munk, Marion |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1539-2864 |
Publisher: |
Wolters Kluwer |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
20 Nov 2023 14:12 |
Last Modified: |
21 Feb 2024 00:13 |
Publisher DOI: |
10.1097/IAE.0000000000003980 |
PubMed ID: |
37972955 |
BORIS DOI: |
10.48350/189127 |
URI: |
https://boris.unibe.ch/id/eprint/189127 |
Actions (login required)
 |
Edit item |