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Blinkeze® External Lid Weights Patient FAQ's


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Blinkeze External Lid Weights are designed for the non-surgical treatment of lagophthalmos, the inability to fully close the upper eyelid. Various circumstances can cause partial or complete paralysis of the muscle controlling upper eyelid movement. Lagophthalmos most commonly results from Bell's palsy, or stroke but can also occur after head trauma, head surgery,
infections, and tumors.

Lagophthalmos can be temporary or permanent and treatment is generally determined by the expected duration of the condition. Blinkeze External Lid Weights offer patients suffering from temporary lagophthalmos a proven method to maintain eye health while the condition resolves. Blinkeze External Lid Weights are provided in a kit, which contains one hundred double-sided, hypoallergenic EyeClose Adhesive Strips (MedDev catalog #LL 0505).

The Adhesive Strips provide a convenient and reliable method of securing the weight to the outer surface of the upper lid. Once adhered to the lid, the weight works by force of gravity to gently pull the eyelid closed during relaxation of the levator muscle. By restoring a functional "blink" mechanism, the Blinkeze External Lid Weight prevents dehydration of the cornea protecting it from further ocular complications.

Blinkeze External Lid Weights are manufactured from pure tantalum, a dense, inert metal with high biocompatibility. The weight's exterior surface is painted in a selection of skin-tones to approximate a patient's complexion. Weights range from 0.6 g to 2.8 g in 0.2 g increments.

DIRECTIONS FOR USE

How do I attach the Blinkeze External Lid Weight to my upper eyelid?

1. Clean the eyelid thoroughly with mild soap and water and let dry. (Moisturizers, make-up, and other cosmetic products used around the eye may not be completely removed using soap and water. Use of these products should be discontinued several days prior to treatment to ensure adequate adhesion).

2. Clean the weight with a mild detergent suitable for hand washing. Rinse thoroughly with water and let dry. Avoid touching the concave side of the weight as oils from your fingers may weaken the adhesive bond.

3. Grasp the clear liner tab of the EyeClose® Adhesive Strip and remove it from the carrier sheet (see fig. 1). The white semi-transparent section of the strip is the adhesive portion.

4. Center the adhesive portion of the strip on the concave side of the weight and press firmly into place (see fig. 2). Continue applying pressure for 30 seconds.
(For weights smaller than 0.8 gm, trim the excess adhesive strip from the end of the weight opposite the clear liner tab before attaching it to the weight).

5. With the EyeClose Adhesive Strip firmly attached to the weight, carefully remove the clear liner tab to expose the adhesive on the strip's opposite side (see fig. 3).
(Because each strip contains specific adhesives of varying strengths, it is important that the adhesive on the liner tab side of the strip always is adhered to the skin and the adhesive on the carrier sheet side of the strip always is adhered to the weight).

6. To correctly position the weight on the eyelid, look into a mirror and center the weight just above the lashes (see fig. 4). Gently press the weight to the eyelid to ensure optimal adhesion.

7. To avoid pulling the skin when removing the weight, gently lift the weight off the eyelid one side at a time.

8. Peel off the old EyeClose Adhesive Strip and discard. Repeat the steps above for applying a new strip.

              

               Figure 1                                    Figure 2                                        Figure 3                                      Figure 4


How Long Can I Wear My Blinkeze External Lid Weight?

The Blinkeze External Lid Weight can be worn on a continuous basis and should be changed only when necessary, preferably after bathing or when the eyelid skin is clean, oil-free, and dry. Medical studies report that weights can be worn for up to three days with no eyelid discomfort.

How do I remove my Blinkeze External Lid Weight?
To remove the Blinkeze External Lid Weight, simply hold both ends of the weight and gently lift the weight off the eyelid one side at a time (so the adhesive does not pull the eyelid skin). Do not remove the weight by pulling both sides of the weight at once as this may cause skin irritation.

How do I clean my Blinkeze External Lid Weight?
The Blinkeze External Lid Weight should be cleaned with mild detergent suitable for hand washing. Rinse thoroughly with water and let dry.

What Problems Should I Watch For?
While complications are rare, the possibility of an adverse reaction does exist. You should not use Blinkeze External Lid Weights if you have known sensitivities or allergies to tantalum or adhesive. As always, if you experience any sensitivity or discomfort while wearing your weight, or if your weight is no longer effective in closing your eyelid, contact your physician.

How do I order more EyeClose® Adhesive Strips?
Patients with a prescription on file with MedDev Corporation should call MedDev Customer Service directly at 800.543.2789 (M-F 8:30 am to 5:00 pm PST) to order additional EyeClose adhesive strips (MedDev Catalog# LL 0505). Each box contains 100 adhesive strips. Payment can be made by credit card, or by mailing a check or money order in advance to MedDev Corporation.

What should I do if I lose my Blinkeze External Lid Weight?
If you lose your Blinkeze External Lid Weight please call MedDev Customer Service to arrange for a replacement weight. There will be a charge for the replacement weight and shipping. Alternatively, your physician may prescribe you two weights at the time of your initial order as a preventative measure.

Is the Blinkeze External Lid Weight covered by my medical insurance?
Presently there is no guarantee that by submitting to your insurance carrier you will be reimbursed for your Blinkeze External Lid Weight. MedDev can provide you with a form letter that may assist you in obtaining reimbursement. Please contact MedDev Customer Service to obtain a copy of this letter.

What if my paralysis does not improve?
If your paralysis does not improve, your physician may suggest other treatments, including the surgical placement of a MedDev Gold or Platinum Eyelid Implant. The implanted weight will be less noticeable, easier to manage and will function similarly to the Blinkeze External Lid Weight.

Are the Blinkeze External Lid Weights only indicated as a treatment for the patient with temporary facial palsy?

No. Blinkeze External Lid Weights can be used as an eyelid closure treatment for both temporary and protracted lagophthalmos. Blinkeze External Lid Weights can also be worn as a trial before implantation to confirm adequate closure.

 

What are the Blinkeze External Weights made of? Why?

Blinkeze External Lid Weights are made of 99.99% pure Tantalum, a dense, inert metal with a high biocompatibility. The weight exterior surface is painted in a skin-tone to approximate a patient's complexion.

 

Are there any published studies discussing treatment of facial palsies with Blinkeze External Lid Weights?

In 1995, UC San Francisco Ophthalmologists, Drs. Seiff, Boerner, and Carter, reported the results of a two year study on the usefulness of External Eyelid Weights to treat ocular exposure associated with facial paralysis1. The study concluded that External Eyelid Weights decreased corneal exposure, decreased reliance on artificial teardrops, and increased patient comfort.

1. Seiff SR, Boerner M, Carter SR. Treatment of Facial Palsies with External Eyelid Weights. American Journal of Ophthalmology, 120: 652-657, 1995.

2.Zwick, Orin M. and Seiff, Stuart R.: Supportive care of facial nerve palsy with temporary external weights. Optometry, 77:340-342, July 2006.


Are there any other adhesives that can be used with Blinkeze External Lid Weights?

In 2001, Drs. Todd Shepler and Stuart Seiff reported the results of a study on the use of Isobutyl Cyanoacrylate Tissue Adhesive1 as an alternative to the double-sided adhesive tape provided by MedDev Corporation. The study reported a mean wear time of 10.7 days, a substantial increase in duration than with the double-sided adhesive tapes.  At this time, the FDA has not approved Isobutyl Cyanoacrylate as an adhesive for use with Blinkeze External Lid Weights.

1. Shepler TR, Seiff SR: Use of Isobutyl Cyanoacrylate Tissue Adhesive to Stabilize External Eyelid Weights in Temporary Treatment of Facial Palsies. Ophthalmic Plastic and Reconstructive Surgery, 19: pp 279, 1996.

How does my physician determine the appropriate size and skin tone color for my Blinkeze External Lid Weight?

A selection of skin tone colors for a Blinkeze External Lid Weight can be viewed on the Skin Tone Selector Card.  During your office visit, your physician will test various weights on your eyelid to determine which weight will pull your eyelid closed and restore your blink function.  After determining the optimal weight, your physician will use the Skin Tone Selector Card to determine the appropriate skin tone that best approximates your complexion.

How can I get more information?
A list of medical articles discussing the treatment of lagophthalmos using eyelid weights is available from MedDev Corporation.



A Medical Development Corporation
730 North Pastoria Avenue
Sunnyvale, CA 94085-3522
Telephone: 800.543.2789
408.730.9702
Facsimile: 408.730.9732
E-Mail: info@meddev-corp.com
Web site: www.meddev-corp.com

© 2004 MedDev Corporation. Blinkeze is a trademark of MedDev Corporation.
EyeClose is a registered trademark of MedDev Corporation. Patent No. 5,542,437.
Other patents pending. Specifications are subject to change without notice.
11-10114 Rev. B