New Prospective Study Shows Significant Reduction In Reports Of Postoperative Halos From Patients Treated With TearScience LipiFlow Treatment Prior To Bilateral Cataract Surgery

SANTA ANA, Calif., July 24, 2021 /PRNewswire/ -- Johnson & Johnson Vision*, a global leader in eye health and part of the Johnson & Johnson Medical Devices Companies**, today 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 vs. 79 percent) and showed larger improvements in Meibomian Gland Score (MGD) than control group (107 vs. 66 percent). The results were shared today in a poster presentation at the American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting.

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, MD.^*** "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 study is available for on-demand viewing in the Education Hub at the convention center during the meeting, and remotely on the ASCRS website post-meeting.

About TearScience LipiFlow
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.

About Johnson & Johnson Vision
At Johnson & Johnson Vision, part of Johnson & Johnson Medical Devices Companies**, we have a bold ambition: to change the trajectory of eye health worldwide. Through our operating companies, we deliver 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, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better, live better. Visit us at jjvision.com, follow @JNJVision on Twitter, Johnson & Johnson Vision on LinkedIn, and @JNJVision on Facebook.

About Johnson & Johnson Medical Devices Companies
At Johnson & Johnson Medical Devices Companies, we are helping people live their best lives. Building on more than a century of expertise, we tackle pressing healthcare challenges, and take bold steps that lead to new standards of care while improving people's healthcare experiences. In surgery, orthopaedics, vision, and interventional solutions, we are helping to save lives and paving the way to a healthier future for everyone, everywhere.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for LIPIFLOW^® Thermal Pulsation System

Rx Only

INDICATIONS: The LipiFlow^® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

CONTRAINDICATIONS: Do not use the LipiFlow^® System in patients with the following conditions.  Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.

• Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
• Ocular injury within prior 3 months
• Ocular herpes of eye or eyelid within prior 3 months
• Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
• Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
• Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
• Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)

PRECAUTIONS: Use of the LipiFlow^® System in patients with the conditions described in the LipiFlow^® instructions for use may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management.  Safety and effectiveness of the device have not been studied in patients with these conditions.

WARNINGS: Caution: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of the device by children or incapacitated persons may be dangerous.

ADVERSE EFFECTS: Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in:

• Eyelid/eye pain requiring discontinuation of the treatment procedure;
• Eyelid irritation or inflammation;
• Ocular surface irritation or inflammation; and
• Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).
• Physical pressure-induced injury to the eyelid; and
• Ocular surface (corneal) infection.

ATTENTION
Reference the LipiFlow Thermal Pulsation System Instructions for Use for a complete listing of indications, warnings, and precautions.

*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, orthopaedics, 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.

© Johnson & Johnson Vision, 2021. All rights reserved.

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

SOURCE Johnson & Johnson Vision