Abstract
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Purpose: To describe how early functional and anatomic observations after repeated low level red light therapy in adults with pathologic myopia were translated into a multicenter randomized sham controlled trial.
Methods: The translational program comprised two stages. First, a prospective real world case series evaluated two adult women with pathologic myopia receiving 650 nm red light at 2 mW for 3 minutes twice daily over 6 months. Best corrected visual acuity, axial length and multimodal imaging were assessed longitudinally. Second, the RAMP trial was designed to randomize 158 adults aged 18 to 55 years in a 1 to 1 ratio to 660 nm LED red light at 65 mW per square centimeter or an identical sham device at 5 mW per square centimeter for 12 months.
Results: In case 1, the treated right eye improved from 20/50 to 20/25 without clear retinal morphologic restoration. In case 2, best corrected visual acuity improved from 20/25 to 20/20 in both eyes; axial length decreased by 0.11 mm in the right eye and 0.14 mm in the left eye. Mean macular retinoschisis cavity height decreased from 162.0 to 112.0 micrometers and from 76.0 to 15.5 micrometers, respectively. These signals informed RAMP outcomes. The primary outcomes are change in choroidal vessel density and choroidal vessel volume index. Secondary outcomes include atrophy progression, retinal and choroidal structure, microperimetry, visual acuity, axial length and prespecified retinal safety measures.
Conclusions: The case series generated a clinical signal but cannot establish efficacy or safety. RAMP converts that signal into a controlled test of mechanism, structure, visual function and risk. This staged approach separates hypothesis generation from therapeutic validation and may provide a reproducible framework for evaluating photobiomodulation in pathologic myopia.
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