Judy E Kim1, Adam R Glassman2, Kristin Josic3, Michele Melia3, Lloyd P Aiello4, Carl Baker5, Janis T Eells6, Lee M Jampol7, Timothy S Kern8, Dennis Marcus9, Hani Salehi-Had10, Sandeep N Shah11, Daniel F Martin12, Cynthia R Stockdale3, Jennifer K Sun4. 1. Medical College of Wisconsin, Milwaukee, WI. 2. Jaeb Center for Health Research, Tampa, FL. Electronic address: drcrstat2@jaeb.org. 3. Jaeb Center for Health Research, Tampa, FL. 4. Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, MA. 5. The Ophthalmology Group, LLC, Paducah, KY. 6. University of Wisconsin-Milwaukee, Milwaukee, WI. 7. Feinberg School of Medicine, Northwestern University, Chicago, Illinois. 8. University of California-Irvine, Irvine, California. 9. Southeast Retina Center, P.C., Augusta, GA. 10. Retina Associates of Southern California, Huntington Beach, CA. 11. Retina Vitreous Center, Edmond, OK. 12. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Abstract
PURPOSE: To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than 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 United States. 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 MEASURES: Change in CST on spectral-domain 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 years, 37% were women, and 82% were White. The 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, with the mean difference (95% confidence interval [CI]) being -2 (-20 to 16) μm (P = 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90%) PBM eyes and 57 (86%) placebo eyes at 4 months (adjusted odds ratio [95% CI] = 1.30 (0.44-3.83); P = 0.63). VA 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 = 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious. CONCLUSIONS: PBM as given in this study, although safe and well-tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.
PURPOSE: To determine if treatment with a photobiomodulation (PBM) device results in greater improvement in central subfield thickness (CST) than 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 United States. 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 MEASURES: Change in CST on spectral-domain 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 years, 37% were women, and 82% were White. The 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, with the mean difference (95% confidence interval [CI]) being -2 (-20 to 16) μm (P = 0.84). CI-DME, based on DRCR Retina Network sex- and machine-based thresholds, was present in 61 (90%) PBM eyes and 57 (86%) placebo eyes at 4 months (adjusted odds ratio [95% CI] = 1.30 (0.44-3.83); P = 0.63). VA 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 = 0.64). There were 8 adverse events possibly related to the PBM device and 2 adverse events possibly related to the placebo device. None were serious. CONCLUSIONS: PBM as given in this study, although safe and well-tolerated, was not found to be effective for the treatment of CI-DME in eyes with good vision.
Authors: Michael J Elman; Lloyd Paul Aiello; Roy W Beck; Neil M Bressler; Susan B Bressler; Allison R Edwards; Frederick L Ferris; Scott M Friedman; Adam R Glassman; Kellee M Miller; Ingrid U Scott; Cynthia R Stockdale; Jennifer K Sun Journal: Ophthalmology Date: 2010-04-28 Impact factor: 12.079
Authors: Quan Dong Nguyen; David M Brown; Dennis M Marcus; David S Boyer; Sunil Patel; Leonard Feiner; Andrea Gibson; Judy Sy; Amy Chen Rundle; J Jill Hopkins; Roman G Rubio; Jason S Ehrlich Journal: Ophthalmology Date: 2012-02-11 Impact factor: 12.079
Authors: John A Wells; Adam R Glassman; Allison R Ayala; Lee M Jampol; Lloyd Paul Aiello; Andrew N Antoszyk; Bambi Arnold-Bush; Carl W Baker; Neil M Bressler; David J Browning; Michael J Elman; Frederick L Ferris; Scott M Friedman; Michele Melia; Dante J Pieramici; Jennifer K Sun; Roy W Beck Journal: N Engl J Med Date: 2015-02-18 Impact factor: 91.245
Authors: Susan B Bressler; Allison R Edwards; Kakarla V Chalam; Neil M Bressler; Adam R Glassman; Glenn J Jaffe; Michele Melia; David D Saggau; Oren Z Plous Journal: JAMA Ophthalmol Date: 2014-09 Impact factor: 7.389
Authors: Jean-François Korobelnik; Diana V Do; Ursula Schmidt-Erfurth; David S Boyer; Frank G Holz; Jeffrey S Heier; Edoardo Midena; Peter K Kaiser; Hiroko Terasaki; Dennis M Marcus; Quan D Nguyen; Glenn J Jaffe; Jason S Slakter; Christian Simader; Yuhwen Soo; Thomas Schmelter; George D Yancopoulos; Neil Stahl; Robert Vitti; Alyson J Berliner; Oliver Zeitz; Carola Metzig; David M Brown Journal: Ophthalmology Date: 2014-07-08 Impact factor: 12.079
Authors: Johnny Tang; Yunpeng Du; Chieh Allen Lee; Ramaprasad Talahalli; Janis T Eells; Timothy S Kern Journal: Invest Ophthalmol Vis Sci Date: 2013-05-01 Impact factor: 4.799
Authors: Carl W Baker; Adam R Glassman; Wesley T Beaulieu; Andrew N Antoszyk; David J Browning; Kakarla V Chalam; Sandeep Grover; Lee M Jampol; Chirag D Jhaveri; Michele Melia; Cynthia R Stockdale; Daniel F Martin; Jennifer K Sun Journal: JAMA Date: 2019-05-21 Impact factor: 56.272