Study Touts Positive Effects of TearScience LipiFlow Treatment

Johnson & Johnson Vision,* a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies,** revealed new comparative clinical study findings evaluating TearScience LipiFlow treatment in cataract surgery. The data concluded that treating patients with TearScience LipiFlow prior to cataract surgery significantly reduced patient-reports of halos compared to control group (58.6 percent vs. 79 percent) and showed larger improvements in Meibomian Gland Score (MGD) than control group (107 percent vs. 66 percent). 
 
The study titled, “Preoperative Treatment of Meibomian Gland Dysfunction with Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation,” was a post-market, prospective, randomized, multi center, bilateral, open-label, cross-over, comparative clinical study covering five U.S. sites and comprising 115 subjects. At three-months following surgery, there were notable differences in the rates of bothersome ocular symptoms, such as seeing halos, between the study and control groups. The findings align with the recent ASCRS clinical guidelines recommending the proactive diagnosis and management of MGD in the preoperative cataract patient.¹   
 
“We continue to learn more about the connection between the health of the ocular surface and visual outcomes following cataract surgery,” said Daniel Chang, M.D.*** “This new data reinforces the importance of proactively screening for and treating MGD prior to cataract surgery. It’s a simple addition to the patient’s treatment plan that may result in better visual outcomes for our patients.” 
 
MGD is a prevalent, chronic, and progressive disease that becomes worse the longer it goes untreated.^2,3,4,5 In the study, presurgical TearScience LipiFlow in cataract patients improved meibomian gland function and improved postoperative anterior ocular health. In addition to reducing postoperative reports of halos, the presurgical treatment also showed measurable improvements in visual acuity (20/20 at 4m, 20/20 at 66cm; 20/30 at 40cm).
 
“As clinicians, we always want to optimize surgical outcomes for cataract patients, including postoperative visits.  The data we unveiled today reinforces the need for surgeons to screen for, and treat, MGD prior-to cataract surgery, especially given the high incidence and asymptomatic nature of ocular surface disease in patients presenting for cataract surgery,” said Rajesh Rajpal, MD, Chief Medical Officer and Global Head of Clinical and Medical Affairs at Johnson & Johnson Vision. 
 
The TearScience LipiFlow Thermal Pulsation System, is a medical device used by physicians in addressing Meibomian Gland Dysfunction (MGD). It consists of a console and a single-use sterile device, known as the Activator, and has a drug-free mechanism of action. Eye care professionals use the TearScience LipiFlow System to treat MGD patients in-office with confidence and efficiency.
 
Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies,** delivers innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts, and dry eye. In communities with greatest need, the company works in collaboration to expand access to quality eye care, and is committed to helping people see better, connect better, live better. 
 
Johnson & Johnson Medical Devices Companies tackles pressing healthcare challenges, and takes bold steps that lead to new standards of care while improving people’s healthcare experiences. In surgery, orthopedics, vision, and interventional solutions,  Johnson & Johnson Medical Devices Companies help save lives and pave the way to a healthier future for everyone, everywhere.
 
* Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
** The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.   
*** Dr. Chang is a paid consultant of Johnson & Johnson Vision, Inc.
***** Dr. Rajesh K. Rajpal is an employee of Johnson & Johnson Surgical Vision, Inc., serving as Head of Clinical and Medical Affairs across both the Surgical Vision and Vision Care organizations.

References 
¹ Starr CE, Gupta PK, Farid M, Beckman KA, Chan CC, Yeu E, Gomes JAP, Ayers BD, Berdahl JP, Holland EJ, Kim T, Mah FS; ASCRS Cornea Clinical Committee. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May;45(5):669-684. doi: 10.1016/j.jcrs.2019.03.023
² Nichols KK, Hanlon SD, Nichols JJ. A murine model for characterizing glandular changes in obstructive meibomian gland dysfunction. ARVO. 2014. Abstract #13-A0002
³ Data on file, 2018 (NCT01808560). Pilot study for treatment of Meibomian Gland Dysfunction (MGD) prior to cataract surgery. Accessed from: https://clinicaltrials.gov/show/NCT1808560
⁴ Data on File, 2021 (NCT03708367). A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice. Accessed from: https://clinicaltrials.gov/ct2/show/NCT03708367 
⁵ Tomlinson A et al. The International Workshop on Meibomian Gland Dysfunction: Report of the Diagnosis Subcommittee. Invest Ophthalmol Vis Sci. 2011;52(4):2006-49