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Clinical Research

Post PRK Asian Female with MGD

Gina Wesley, OD, MS, FAAO; Medina Minnesota

KEY POINTS:

  • Symptoms of ocular dryness in the OR and throughout the day was the main complaint of this OB/GYN 
  • Marked reduction of gland function and structure are noted. 
  • A single LipiFlow® treatment was effective in improving gland function and subjective assessment  
     

Introduction

A 46-yo Asian female presented to the office for a comprehensive eye exam. She was an OB/GYN with a history of PRK in 2012. Her main complaint was symptoms of ocular dryness she felt when in the operating room, and throughout the day when working with patients. She noted visual glare, problems with reflections and droopy eye lids. Her health history was positive for eczema, ocular history included 10+ years of using artificial tears of various types. The patient reported that she felt like nothing else could be done, although she was willing to hear about further options.

 

Examination and Testing

Comprehensive exam revealed unremarkable internal ocular health. Uncorrected VA’s were 20/20 OD and 20/25 OS. Anterior segment exam showed moderate meibomian gland dysfunction, with 2 glands OD and 1 gland OS yielding meibum upon meibomian gland evaluation of the lower lids, thus notable loss of gland function. Dermatochalasis Grade 1 OU, and inferior corneal staining of Grade 1 OD and Gr 2 OS. Further discussion ensued about her dry eye, and we scheduled her back for an Ocular Surface Evaluation a few weeks later.

At her subsequent appointment, meibography showed degree 1 loss OU thus notable gland loss.

There was moderate exposure when testing for microlagophthalmos. Tear lab osmolarity testing showed 322 OD, 353 OS, although MMP9® testing was negative OU. Osmolarity above 308 level and greater than 10 between eyes raises concern of tear film homeostasis. Lissamine green staining was Gr 1 OU bulbar conjunctiva and Line of Marx staining was Gr 2 OU. Partial blinks were greater than 50% of the time evaluated. SPEED survey was 23/28, indicating highly symptomatic as expected per her reports.

Figure 1: OD Meibography

In review this patient has marked reduction of gland function and structure. Tear osmolarity was elevated with a notable difference between eyes. Corneal and conjunctival staining was notable, she had a high rate of incomplete blinking and was very symptomatic per SPEED. 

Figure 2: OS Meibography

The patient was educated about LipiFlow® treatment along with her candidacy and expected outcomes. She elected to proceed and had an uncomplicated procedure on the day of evaluation. Post treatment she was instructed to begin a daily regimen OU of warm compresses with massage for 10 min bid, lid foam cleanser bid, preservative-free artificial tears at least bid, and daily omega-3 supplementation of 2000 mg with at least half of that supplement being of a high-quality DHA/EPA component.

 

Post Treatments

Patient returned for her 8-weekfollow-up reporting taking her omega supplement, doing warm compresses/massage bid OU (although did forget at times) and using preservative-free artificial tears prn. Her new SPEED score was now 11/28. Meibomian gland evaluation score was now showing 7 glands OD, and 6 OS yielding fluid. Tear Lab osmolarity was now 308 OD, 310 OS. She also reported feeling much better and was overall very pleased with her treatment outcome.

This patient shows the possible risk associated with Asian ethnicity. The recent TFOS DEWS II Epidemiology Report identified Asian ethnicity to be a mostly consistent risk factor for dry eye development1, and in a recent study by Jennifer Craig2 Asian patients are more likely to be symptomatic than Caucasian counterparts, with possibly poorer meibomian gland function and greater degrees of incomplete blinks.

By treating with LipiFlow®, the hope is to improve function and preserve the remaining glands which was noted here with meibomian gland function improving from 2 OD and 1 OS to 7 OD and 6 OS yielding fluid. Further evidence of improvement was noted by the improvement in tear osmolarity.  Symptomatic improvement is the additional benefit as was noted here with the SPEED score improving from 23 to 11. This patient asked for an annual treatment to stay ahead of her dry eye disease.


1. F. Stapleton, M. Alves, V.Y. Bunya, I. Jalbert, K. Lekhanont, F. Malet, et al.TFOS DEWS II epidemiology report. Ocul Surf, 15 (2017), pp. 334-365
2. Craig, J.P., The Ocular Surface, https://doi.org/10.1016/j.jtos.2018.09. 


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
The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices.  Use of the LipiFlow® System in patients with the following conditions 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. 

  • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
  • Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use.
  • Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren's syndrome)
  • Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines)
  • Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)

In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

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 (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion);
  • Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)); and
  • Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light).

Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include: 

  • Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens;
  • 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.

LIPIFLOW is a trademark of TearScience, Inc.  
© Johnson & Johnson Surgical Vision, Inc. 2019
All other trademarks are the intellectual property of their respective owners.

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