Physician Information - Lagophthalmos


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I’ve got a patient who is an excellent candidate for an Eyelid Implant; what’s my next step? How do I go about ordering this product?

First you must determine the correct Eyelid implant design and weight for your patient. This can be done using MedDev’s Tantalum Weight Sizing Set. Once the appropriate weight size is determined, the corresponding ThinProfile or Contour Eyelid Implant can be ordered.

Note: Most MedDev products are in stock and available for immediate delivery.

How do I determine the correct size implant for my patient?

The easiest way of doing this is to order a Tantalum Weight Sizing Set. The Standard Sizing Set consists of seven testing weights that correspond to the most commonly ordered implant sizes. The set also includes a supply of double-stick, hypoallergenic adhesive strips to adhere the testing weights to the upper lid. Alternatively, any medical grade adhesive can be used for adhesion. The two most commonly used are Mastisol and Benzoin.

Sizing is done preoperatively. Following are MedDev’s sizing instructions:

1. Place the EyeClose® Adhesive Strip on the concave side of the 1.0 gram sizing weight. (Note: Instructions for use of the tape are included in the adhesive tape box.)

2. With the patient sitting upright, affix the weight to the upper eyelid approximately 3.0 mm above the lash line, centered at the junction of the medial and central thirds of the eyelid (See Figure 1). At this point the action of the levator function is maximal.

3. Note the position of the eyelid as the patient looks up and down.

4. Increase or decrease the sizing weight until the best result is achieved. Because the levator seems to strengthen after the weight is added, the optimal weight is usually that which holds the lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.

Once the appropriate weight size is determined, the corresponding implant, in the implant design of preference, can then be ordered for the procedure.

How soon after the onset of facial paralysis and lagophthalmos should the patient receive a Gold Eyelid Implant?

The patient who has lagophthalmos with the diagnosis of prolonged or incomplete recovery is a suitable candidate for the procedure. If the facial nerve is felt to be intact and likely to recover, such as in Bell’s palsy, supportive care using a Blinkeze External Lid Weight in conjunction with ocular lubricants can be indicated for the first six months, during which time the facial nerve function can be monitored. If the paralysis resolves after implantation of an Eyelid Weight, the procedure is easily reversed.

 

What’s involved in the procedure?

Final placement of the Eyelid Implant may be septal, mid-pretarsal or low-pretarsal. Recognizing that surgical technique is a matter of individual surgeon preference, MedDev presents two representative techniques from Drs. Richard Jobe1 and Stuart Seiff2 respectively.

SEPTAL FIXATION

Local or general anesthesia may be used. A 1.5 cm to 2.0 cm incision is made horizontally in the deep portion of the upper lid sulcus. The incision should be centered at the juncture of the medial and central thirds of the lid. It should be carried just through the orbicularis muscle fibers to the plane beneath the orbicularis.

By blunt dissection, the plane is opened to make room for the implant on the surface of the orbital septum and the tarsal plate. Usually, the Gold Eyelid Implant will rest more comfortably with its lower edge 4 to 5 mm above the lid margin. The implant is placed with the rounded corners down. The implant is tied to the orbital septum with a single 6-0 non-absorbable suture to hold it in place until the tissues heal around it and through the suture holes. If the Gold Eyelid Implant does not sit comfortably parallel to the lid margin, then another suture should be placed.

The implant is placed a short distance above the lid margin so that it will not be evident in the thinnest portion of the lid. A slight bulge may nevertheless be visible.

The skin and orbicularis are closed by the method of the surgeon’s choice.

PRETARSAL FIXATION

Local or general anesthesia may be used. The lid crease is marked. A 4-0 black silk suture is placed near the upper lid margin to allow for downward traction. A blade is used to incise at the lid crease through skin and orbicularis. Scissors dissection is performed inferiorly into the pretarsal space. The levator aponeurosis is stripped from its attachments to tarsus in the area of planned implantation, thus baring the anterior tarsal surface and effecting a modest levator recession. Hemostasis is achieved. The previously selected Gold Eyelid Implant, which has been thoroughly cleaned and sterilized, is centered over the bare superior tarsal surface. The implant is placed with the rounded corners down. Sutures are placed through the holes in the implant directly to the tarsus using 5-0 polyglactin sutures on spatula needles. Antibiotic solution is irrigated into the wound. Orbicularis is closed over the implant with interrupted 6-0 polyglactin sutures. The traction suture is removed and the skin is closed with a running 6-0 silk or nylon suture. Antibiotic ointment is placed over the wound and a double eye pad is applied.

ADVANTAGES OF THE SURGICAL PROCEDURE

  1. Clinically proven with a low rate of complications (a 92% reported surgical success rate3)

  2. Straightforward procedure; relatively easy to learn
  3. Reversible procedure if normal eyelid function is regained
  4. Outpatient procedure, can be performed under local anesthesia
  5. Permits rapid patient recovery, an immediately functional eyelid and improves distribution of tear film to the cornea
  6. Procedure produces aesthetically pleasing outcome, high level of patient satisfaction

1. Townsend DJ: Eyelid reanimation for the treatment of paralytic lagophthalmos: Historical perspectives and current applications of the gold weight implant. Ophthalmic Plastic and Reconstructive Surgery 8(3): pp 196-201, 1992.

2. Jobe RP: A technique for lid loading in the management of lagophthalmos of facial palsy. Plastic and Reconstructive Surgery, 53: pp 29-32, 1974.

3. Seiff SR, Sullivan JH, Freeman LN, Ahn J: Pretarsal fixation of gold weights in facial nerve palsy. Ophthalmic Plastic and Reconstructive Surgery 5(2): pp 104-109, 1989.

What type of suture is typically used?

Typically, a 5-0 polyglactin absorbable or 6-0 silk or nylon, non-absorbable is used. Sometimes a 4-0 black silk is used.

 

Is the implant sutured to the tarsus?

Yes, implant placement is typically sutured to the anterior surface of the tarsus. Yet several surgeons place the implant on the edge of the orbicularis inferiorly so that the implant is better hidden in the lid crease and is less conspicuous. The functional postoperative results are the same in either placement. A septal placement may be indicated in cosmetic considerations.

 

Are the implants sutured with the rounded corners (side with the most suture holes) up or down?

In both of the surgical techniques for pre-tarsal and septal fixation the implant is placed with the rounded corners down.

 

Will the eyelid close with the patient sleeping in the supine position?

The orbital septum that extends from the upper portion of the tarsal plate to the upper orbital rim is a thin sheet of fibrous tissue that attaches to the orbit just below the eyebrow. When the eye is closed lying down, this tissue is relatively flat, preventing the Eyelid Weight from going back into the orbit. If the weight is placed incorrectly behind the orbital septum, it can inadvertently pull the lid open, as the weight falls back towards the orbit on the surface of the levator muscle that is behind the orbital septum.

 

What is typical postoperative recovery?

Eyelid edema and erythema that is experienced postoperative is typically minimal and is usually resolved within the first few weeks. In the unlikely event there remains excessive swelling, the inflammation has been treated successfully in some instances with warm compresses. Prolonged or progressive swelling may indicate a noninfectious inflammatory reaction to the Gold Eyelid Implant or a relatively non-virulent infection. Although gold sensitivities at a 99.99% purity level are rare, known gold allergies should be considered in the preoperative history. Persistent reaction is an indication for implant removal and replacement with a Platinum Implant.

Drs. Bair, Harris, Lyon and Komoroski reported in 1995 in Journal of Ophthalmic Plastic and Reconstructive Surgery on their findings regarding three cases of eyelid inflammation associated with Gold Eyelid Weights1 The cases were successfully treated with either corticosteroid injection or, in the second patient case, with the replacement of the Gold Weight with a MedDev Implant constructed of pure platinum.

1. Bair RL, Harris GJ, Lyon DB, Komorowski RA: Noninfectious inflammatory response to gold weight eyelid implants. Ophthalmic Plastic and Reconstructive Surgery, 11(3): pp 209-214, 1995

Have the implants been reported to extrude from the eyelid?

Pickford reported an extrusion rate of 12% among 41 patients in an article published in the British Journal of Plastic Surgery1. These implants, however, were not designed with suture holes through which adhesions could form for secure, permanent fixation.

In response to the Pickford article, MedDev Corporation polled the surgeons who use Gold Eyelid Implants to determine their incidence of infection and extrusion. The incidence of infection and extrusion among 168 surgeons reporting on over 2000 cases were 0.3% for infection and 2.6% for extrusion. This low complication rate is a testament to the excellent quality and design of the MedDev Eyelid Implants.

1. Pickford MA, Scamp T, Harrison DH: Morbidity after gold weight insertion into the upper eyelid in facial palsy. British Journal of Plastic Surgery, 45: pp. 460-464, 1992.

What are the features of the new ThinProfile(tm) implant?

The new ThinProfile Implant is the thinnest available implant available to optimize lid cosmesis. The ThinProfile implant incorporates the following significant design features:

  • 40% thinner than MedDev’s Contour Implant.
  • Channel free holes for freedom in suturing position
  • Spherically curved lower implant profile
  • Optimal length for maximum levator function
  • Precisely tapered edges and smoothly rounded corners

Does MRI affect Gold Eyelid Implants?

No, JW Canady published an article in the Annals of Plastic Surgery (31: 76-77, 1993) reporting on an ex-vivo study which showed no deflection of the Gold Implants at 0.5 tesla and 1.5 tesla. The Gold Eyelid Implant is 99.99% pure gold. There are no ferrous metals in these devices.

Additional study by Mark May published in Laryngoscope (103: August 1993: p. 93) reported no magnetic effects from the use of MRI with the Gold Eyelid Implants but did mention that the implant may become warm when bombarded with radio waves.

Why is gold used in manufacturing Eyelid Implants?

Gold is preferred because it is a heavy, inert metal that does not corrode or cause irritation to the eyelid tissue. Gold is also preferred because its color closely matches that of the eyelid’s fat, making the implant less conspicuous in the eyelid, even in patients with thin skin.

 

What carat of gold is used?

The implants are manufactured from 24K gold. Prior to production, each lot of gold or platinum is analyzed by an independent laboratory for the purity levels of all known trace elements using an Emission Spectrophotometer (E-Spec) on a sample of the solid material. A broad-spectrum film is read and all impurities seen are reported in their indicated concentrations. While the analysis results may vary from lot to lot, no lot is accepted for production that is not 99.99% pure and has certain trace elements below their specified limits.

For additional information, Contact Us or Call MedDev Customer Service at 800.543.2789 (M-F 8:30 am – 5 pm PST).