ABSTRACT
Purpose : Dry age-related macular degeneration (AMD) is a leading contributor to visual impairment across the globe. No current treatment exists to improve visual function or reduce disease progression outside of vitamin supplementation and lifestyle changes. LIGHTSITE III is evaluating multiwavelength photobiomodulation (PBM) therapy using the LumiThera Valeda® Light Delivery System in dry AMD Methods : LIGHTSITE III (NCT04065490) is a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of PBM in dry AMD. Target enrollment was approximately 96 subjects (144 eyes). Subjects are treated with six series of PBM/Sham treatments (3x per week for 3 weeks) delivered over a 24-month period with a 13-month efficacy analysis of data. PBM therapy consists of low-level light exposure to selected tissues resulting in positive effects on mitochondrial output and improvement in cellular activity. Valeda is used to deliver multiwavelength PBM treatment using 590, 660 and 850 nm of light. Subjects are assessed for clinical and safety outcomes (i.e., best-corrected visual acuity (BCVA), low- luminance BCVA, contrast sensitivity, reading speed, color vision, VFQ-25 and perimetry). Independent OCT, FAF and color fundus imaging outcomes at selected timepoints are analyzed by a masked imaging reading center Results : A total of 148 eyes from 100 subjects with dry AMD have been enrolled and randomized in a 2:1 design (PBM:Sham). The majority of subjects are female (68%) and Caucasian (99%). The average age at enrollment was 75 years and mean time since dry AMD diagnosis is 4.9 years. COVID-19 interference has been minimal and not significantly impacted subject enrollment or retention. Clinical and anatomical outcome data from the interim analysis conducted at Month 13 is presented. Results from the 21-month time point are expected at end of 2022 Conclusions : LIGHTSITE III provides the largest, randomized controlled trial evaluating the effects of PBM in dry AMD subjects. PBM therapy may offer a new treatment strategy with a unique mechanism and modality for patients with dry AMD.
ABSTRACT
Purpose : COVID-19 pandemic has become a major global public health challenge. The ophthalmology office setting involves close encounters between the patient and the health care workers increasing risk of viral transmission. Use of PPE decreases risk of person-to-person viral transmission. The purpose of the study was to evaluate breath-induced air currents in subjects without a facemask, with a procedure mask, with an improvised face, and in the setting of slit-lamp examination. Methods : Breath-induced air currents were studied in healthy volunteers utilizing a vape pod system and videography during gentle and heavy breathing simulation. Video frames at 2 seconds after the initiation of expiration were captured and analyzed. Results : A total of 210 recordings were made for 7 settings. Without a face mask, the aerosol moved forwards and spread vertically and horizontally reaching a mean distance of 23.1 inches for gentle, and 36.1 inches for heavy breathing at 2 seconds (P< 0.001). Using PPE the airflow patterns included: a) procedure mask- forward 0 cases, upward 19 (63%) cases, side 28 (93%) cases, downward 22 (73%) cases, and backward 22 (73%) cases. Adding a tape at the upper border of the mask eliminated upward flow in all cases. b) Improvised face mask- forward 0 cases, upward 0 cases, side 30 (100%) cases, downward 30 (100%) cases, and backward 17 (57%) cases. In 14 (47%) cases trace of aerosol was detected adjacent to the front surface of the mask. Adding a second layer eliminated the trace of aerosol in all cases. In the setting of simulated slit-lamp examination without the breath shield, the aerosol reached the chin rest in 9 (60%) cases during gentle breathing and in all cases during heavy breathing. The breath shield was effective in blocking forward airflow in all cases. Conclusions : Use of a procedure mask by patients, while effective in blocking forward breath-induced airflow, redirects the flow upwards, potentially increasing the risk of contamination during an office procedure. An improvised facemask alters breath-induced air currents favorably and partially absorbs respiratory droplets.