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A Randomized Trial of Photobiomodulation Therapy for Center-Involved Diabetic Macular Edema with Good Visual Acuity (Protocol AE)

Published:October 07, 2021DOI:https://doi.org/10.1016/j.oret.2021.10.003

      Highlights

      • Précis: Photobiomodulation, as used in this study, did not improve central subfield thickness in eyes with center-involved diabetic macular edema and good vision

      Abstract

      Purpose

      To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness as compared with placebo in eyes with center-involved diabetic macular edema (CI-DME) and good vision

      Design

      Phase 2 randomized clinical trial

      Participants

      Participants had CI-DME and visual acuity (VA) 20/25 or better in the study eye and were recruited from 23 clinical sites in the US.

      Methods

      One eye of each participant was randomly assigned 1:1 to a 670-nm light-emitting PBM eye patch or an identical device emitting broad-spectrum white light at low power. Treatment was applied for 90 seconds twice daily for 4 months.

      Main Outcome Measure

      Change in central subfield thickness (CST) on spectral-domain optical coherence tomography (OCT) at 4 months.

      Results

      From April 2019 to February 2020, 135 adults were randomly assigned to either PBM (N = 69) or placebo (N = 66); median age was 62, 37% were female and 82% were white. Median device compliance was 92% with PBM and 95% with placebo. OCT CST increased from baseline to 4 months by a mean (SD) of 13 (53) μm in PBM eyes and 15 (57) μm in placebo eyes (mean difference (95% CI) = -2 (-20 to 16) μm; p = .84). CI-DME, based on DRCR Retina Network sex and machine-based thresholds, was present in 61 (90%) of PBM eyes and 57 (86%) of placebo eyes at 4 months (adjusted odds ratio (95% CI) = 1.30 (0.44 to 3.83); p = .63). Visual acuity decreased by a mean (SD) of -0.2 (5.5) letters and -0.6 (4.6) letters in the PBM and placebo groups, respectively (difference (95% CI) = 0.4 (-1.3 to 2.0) letters; p = .64). There were eight adverse events possibly related to the PBM device, and two adverse events possibly related to the placebo device. None were serious.

      Conclusions

      PBM as given in this study, while safe and well tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.
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      References

      1. International Diabetes Federation. Diabetes facts and figures: IDF Diabetes Atlas Ninth edition 2019. https://idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html. Accessed 23 June 2021.

      2. National Eye Institute. Facts about diabetic eye disease. 2015; https://nei.nih.gov/health/diabetic/retinopathy.

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