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Intraductal Meibomian Gland Probing to Restore Gland Functionality for Obstructive Meibomian Gland Dysfunction (MGD)

Steven L. Maskin, MD FACS and Kelly Kantor.
Dry Eye and Cornea Treatment Center, Tampa, Florida.

Disclosure: patent pending.
Commercial relationship: Rhein Medical, inc.

Follow Up Of Original Meibomian Gland Probing Cases ( CORNEA 29(10): 1145-1152, October 2010 )

Background:

Meibomian gland dysfunction (MGD) is arguably the most common cause of dry eye and has certainly been the most challenging to treat. Traditional therapies have failed to consistently provide effective results leading to ongoing suffering and frustration for patients and physicians alike.

Purpose:

To take a retrospective look at the longer term follow up of the initial 25 patients treated with intraductal meibomian gland probing (MGP) for obstructive MGD reported at ARVO 2009, 2010, and 2011 meetings.

Methods:

Charts were reviewed looking at numbers of patients with follow up, length of follow up, status of symptoms at last follow up and number of patients needing retreatment.

Results:

Twenty one (84%) of the initial group of twenty five patients had at least 12 months follow up with an average of 28.9 ± 10.3 months follow up. Follow up was by office exam in 16, by phone in 3, and email in 2 patients. Follow up was unavailable in 2 patients, and 2 patients had died. Fourteen patients did not need retreatment (66.7%) with a male to female ratio of 5/9. The range of follow up for non retreated patients was 17 to 46 months with an average of 30.3 ± 10.5 months. These 14 patients had a total of 23 lids treated. For the seven patients needing retreatment (33.3%) there was an overall range of 12 to 42 months follow up with average 26.0 ± 9.88 months with a male to female ratio of 2/5. These seven patients had 14 lids retreated out of 19 lids overall treated with an average interval for first retreatment at 10.3 ± 9.43 months with a range of 1 to 27 months. Seven of the fourteen retreated lids were retreated a second time. At the last follow up, all the patients reported ongoing improvement. No patient had worse symptoms and no adverse sequelae of probing were noted.

BACKGROUND STUDIES

Background:

Previous reviews looked at MGP for MGD symptoms of lid tenderness (LT) and except lid tenderness (XLT) without intraductal microtube steroid injection using Visual Analog Scale (VAS) to evaluate symptoms. The results showed two discrete types of VAS response profiles with LT responding immediately to 75% improvement maintaining between 74 and 90% through 9-12 months suggesting that equilibration of elevated intraductal pressure led to relief. For XLT, improvement was 35% immediately with gradual improvement to 80% by 3 to 6 months suggesting improvement through removal of stagnant intraductal contents and reduction of glandular inflammation leading to improved gland function.

We also looked at MGP with adjunctive intraductal microtube steroid injection in patients with MGD and more severe symptoms and/or signs including lid tenderness (LT) and excluding lid tenderness (XLT). Visual Analog Scale (VAS) was used to evaluate symptoms. For LT, the results showed a gradual response from 58 % reduction in symptoms immediately to 91 % at 1 month ! 3 months then maintained between 80 % and 91 % through 12 months follow up. For XLT, improvement was 45 % immediately with improvement to 63 % at 1 month and maintaining improvement in the 60 percentile until the latest follow up at > 6 months < 9 months.

FOLLOW UP STUDIES

RESTORING FUNCTIONALITY AFTER MGP

PURPOSE:

To retrospectively look at the restoration of meibum secreting lid functionality after probing. This was for all lids that had an initial diagnosis of non functional (NF) meibum secreting lids pre probing. Pre-probe diagnosis of NF lids could be categorized as complete distal obstruction (CDO) or complete distal obstruction non-functional (CDO NF). See nearby MGP classification diagram. Functionality means the patient must have at least 5 expressible glands in a lid with a maximum number of glands counted being 10 glands per lid.

METHODS:

During examination, digital diagnostic expression was performed on each lid to see if there was a presence or absence of meibum secreted. A classification system was generated to explain the differences in functionality between NF meibum secreting lids and functional (F) meibum secreting lids.

RESULTS:

Post probing meibum secreting lid functionality was evaluated in 67 lids of 36 patients with initial NF lids. The average age was 64.5 ± 12.8, with a M/F ratio of 5/31. Sixty two lids became functional and remained functional until their last follow up at average of 7.65 ± 6.82 weeks with a range of ! of a week to 7 months. Three initial NF lids have remained NF until their last follow up but all three lids, increased the number of glands expressible per lid. Two lids started NF became functional but became NF again at their last follow up visit. At the initial pre-probe time, zero lids were functional with 2.31 ± 1.45 glands expressible per lid. When measuring functionality from any time less than or equal to one week after probing, 89 % (25/28) of the lids measured were functioning with 8.00 ± 2.67 glands expressible per lid. At greater than one week and less than or equal to one month post probing, 83 % (39/47) lids were functional with 7.94 ± 2.34 glands expressible per lid. At greater than one month and less than or equal to three months after probing, 94 % (30/32) lids were functioning with 8.74 ± 1.66 glands expressible per lid. At greater than three months and less than or equal to seven months post probing, 92 % (12/13) lids were functioning with 8.57 ± 2.23 glands expressible per lid. The NF lids became functional at average 2.55 ± 2.13 weeks post probing and average last recorded expressible gland count was 8.10 ± 2.26 glands.

FINDINGS

Probing often identified four findings. Three of the four findings were of variable resistance which may be present in each gland. These included: (1) orifice resistance, (2) a mostly proximal gritty sensation like piercing through a “rice krispy”, and (3) moderate resistance which released with a “pop” and was usually deeper in the duct and suggestive of fibrovascular tissue. (4) The fourth finding was frequent orifice hemorrhages which were self limited. There were no probe fractures in these studies. There were no adverse sequelae.

TECHNIQUE

(1) The lid margin and glands were examined with and without trans-illumination to evaluate patency of orifice and status of the glands, specifically looking at gland proximal and distal atrophy, length of glands and signs of ductal dilation suggestive of proximal obstruction. Glands were palpated individually for gland tenderness seen with inflammation and obstruction, with presumed elevated intraductal pressure. (2) To anesthetize, first place a bandage contact lens over the cornea, then place a drop of proparacaine 0.5% or tetracaine 0.5% solution in the conjunctival sac. Then place a generous amount of jojoba ophthalmic anesthetic ointment on the lower lid margin using sterile cotton tipped applicator. Have the patient close their lids for 10-15 minutes. There will be some mild burning which gradually dissipates over 30 seconds. After 15 minutes, the patients opens eyes, and place another drop of the topical anesthetic solution into the conjunctival sac and remove bandage contact lens then rinse residual anesthetic ointment off ocular surface. Start with the shortest and stiffest probe, the 1 mm length probe. (3) After penetrating the orifice with the 1 or 2 mm, the 4 or 6 mm probe was then used depending on the length of the gland to achieve complete patency of the ductal highway. (4) At times resistance was encountered. Respecting the length of the gland prevented extending the probing too far.

Therefore, if resistance was obtained, the probe was felt to be against a fibrotic band. After checking to ensure the probe was co-linear to the gland, additional mild force was used to pop through the intraductal fibrotic tissue. (5) After completion of regular probing, seat dilator probe on orifice and advance into distal duct about 1mm. (6) With steroid in tuberculin syringe with attached microtube, advance plunger to eliminate air, then place through dilated orifice into distal duct and inject approximately 10ul into each gland. (7) Rinse eye copiously with saline to remove residual anesthetic and use cotton tipped applicator to remove anesthetic from lashes. (8) Have patient use artificial tears every 30 to 60 minutes until bedtime.

CONCLUSION

(1) MG Probing was highly successful in restoring meibum secreting lid functionality persisting up to at least 7 months. (2) MG Probing rapidly increased number of expressible glands per lid which was maintained up to at least 7 months post probing. (3) Improved meibum secreting lid functionality and number of expressible glands may explain the marked positive therapeutic effects of MG Probing previously reported. (4) A qualitative classification of MGD based on probing findings and slit lamp examination is proposed to help understand gland status. (5) MG Probing plus intraductal microtube steroid injection (MGP (s) ) was successfully accomplished with presently available technology and was well tolerated by patients after topical anesthetic without adverse sequelae with longest follow up at 46 months. (6) Meibomian Gland intraductal microtubes are available in two different inner diameters to enable injection of aqueous solutions as well as small particle therapeutic suspensions. (7) MGP(s) may enable even greater symptom reduction than MGP alone in select cases of moderate to severe symptoms and/or signs, significant co-morbid disease, retreatment and possibly chalazion.

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Intraductal Meibomian Gland Probing
Relieves Symptoms Of Obstructive
Meibomian Gland Dysfunction

Steven L. Maskin, MD

Disclosure: patent pending.
Commercial relationship: Rhein Medical

Background:

Meibomian Gland Disease is arguably the most common cause of dry eye and has certainly been the most challenging to treat. Traditional therapies have failed to consistently provide effective results leading to ongoing suffering and frustration for patients and physicians alike.

Purpose:

We have taken a retrospective look at the efficacy of a new invasive approach to treat symptomatic obstructive MGD.

Methods:

A patent pending method and disposable instrument with stainless steel tip were used to perform intraductal probing of 25 consecutive patients with obstructive MGD.

Results:

20 of 25 patients complained of pre-treatment lid tenderness or soreness which was immediately relieved with probing. At one month post procedure each (100%) of these 20 patients continued to have decreased tenderness or soreness.

Findings:

Suggestion of intraductal fibrotic and neovascular membranes were frequently identified. These were able to be opened up by probing allowing sequestered plug of meibum to escape.

Technique:

We have 2, 4, and 6 mm stainless steel sterile solid wire probe cannulas available with attachable ergonomic handle.

The lid margin and glands are examined with and without transillumination to evaluate patency of orifice and status of the glands, specifically looking at gland proximal and distal atrophy, length of glands and signs of ductal dilation suggestive of proximal obstruction. Palpate glands individually for gland tenderness seen with inflammation and obstruction.

With transillumination.

Without transillumination.

Begin by passing the 2 mm probe through the orifice. A fine router movement may be needed to find the opening, especially in setting of orifice metaplasia. After penetrating the orifice with the 2 mm, the 4 or 6 mm probe is used depending on the length of the gland to achieve complete patency of the ductal highway.

Resistance may be encountered. Respecting the length of the gland will prevent extending the probing too far. Therefore, if resistance is obtained, the probe may be up against a fibrotic band. Check to ensure the probe is co-linear to the gland, then provide additional force to pop through the intraductal scar.

Penetration with a 2mm probe. Note heme at orifice of adjacent gland.

4mm probe with transillumination.

At times a drop of heme will be noticed at an orifice. (see photo above) this may occur as the probe passes through a fibrotic neovascular scar or simply a neovascular membrane.

A plug of Sequestered meibum.

Photo above is an example of a plug of meibum freed up from behind a neovascular membrane. Notice the meibum being released adherent to the probe and a drop of heme at the orifice.

DR1 lipid interferometry:

Below is a DR1 lipid interferometry courtesy of Dr. Scheffer Tseng showing views before and after probing. Note the dramatic increase in tear film brown and blue lipid after probing.

Lipid interferometry- before

Lipid interferometry- after

Clinical photos:

Below is a before and after photo showing less deep lid margin redness, less prominent superficial vessels and reduced orifice pouting. Together these findings suggest reduced congestion correlating with the immediate and dramatic reduction in tenderness.

Conclusions:

Intraductal fibrotic and neovascular changes may explain the persistence of obstructive mgd despite exhaustive therapies directed at the lid margin and orifice and the inconsistent effect of warm compresses and lid massage. Intraductal meibomian gland probing appears highly effective in quickly relieving inflammatory symptoms of obstructive MGD.

Dry Eye and Eye Surface Disease

Over 30 million Americans have dry eye. And if you include the number of persons who live with or socialize with a person with dry eye, the number of affected Americans easily surpasses 75 million. This is pertinent because significant others must respect the needs of their spouse/friend/relative with dry eye and help create a dry eye friendly environment.

There have been significant advances in the understanding of dry eye and eye surface disorders over the past several years. These advances have increased our ability to successfully diagnose and treat common and rare eye surface disorders. For common eye surface disorders such as dry eye, irritated eye, red eye, as well as contact lens intolerance and eye infections, new medical therapies and approaches to treatment can restore a comfortable, healthy eye with improved vision.

In some cases medical therapy alone is insufficient to relieve symptoms. In what has become an exciting breakthrough in therapy for intractable eye surface disease, placenta tissue, or amniotic membrane, obtained at elective Cesarean section, is used to resurface the eye. Amniotic membrane surgery has elevated the standard of care for eye surface diseases to a whole new level. Importantly, the tissue contains no viable cells and, therefore, cannot be rejected.

Eye resurfacing surgery is a day surgery performed under local anesthesia with sedation.

Cornea Transplant Surgery

The cornea is a dime sized clear tissue that is the front of the eyeball. It allows light to pass through it to reach the back of the eye, where photochemical signals relay the visual message to the brain.

An unhealthy cornea prevents light from entering the eye thus, blurring or in advanced cases, blinding an individual. This occurs, for example, when the cornea is swollen, or scarred, or irregular as in the disorder known as Keratoconus.

Cornea transplantation can successfully replace these unhealthy corneas with a healthy new one, thereby, restoring vision. Cornea transplants have been performed for several decades and approximately 40,000 are done in the USA yearly. New understandings and therapies of eye surface disease in tandem with advances in cornea transplantation have allowed for greater cornea transplant success than ever before.

What is DSAEK?

DSAEK is a cornea transplant technique where the unhealthy, diseased, posterior portion of a patient's cornea is removed and replaced with healthy donor tissue obtained from the eye bank. Unlike conventional cornea transplant surgery known as penetrating keratoplasty (PKP), the DSAEK procedure utilizes a much smaller surgical incision and requires no cornea sutures. This usually results in more rapid visual rehabilitation for the DSAEK patient (weeks rather than years) and also reduces the risk of sight threatening complications that may occur with the PKP procedure such as intraoperative expulsive hemorrhage or post operative traumatic wound rupture.

Who is a candidate?

DSAEK is indicated for those patients who have cornea pathology located on the posterior aspect of their cornea known as the endothelial layer. The endothelial layer of the cornea is a monolayer of cells attached to a basement membrane called Descemet's membrane. A healthy endothelial layer consists of small, hexagonally shaped cells with a density of 2500 to 3000 cells/mm2.

When endothelial cells are healthy, they function as a "pump-leak system" to provide nourishment for the cornea. In other words these cells allow nourishing fluid from inside the eye (aqueous humor) to leak into the cornea. After the cornea cells have been nourished, the cells pump the fluid out of the cornea. If the endothelial pump is compromised for any reason the cornea will over hydrate and become cloudy. This most commonly occurs in patients who have sustained trauma to the endothelial layer during complicated cataract surgery or patients who have an inherited disease of the cornea endothelium known as Fuchs' Endothelial Dystrophy.

When the cornea endothelium is stressed, the endothelial cells become larger and more sparse. As endothelial cell density falls between 500 to 1000 cells/mm, the pump mechanism can no longer maintain a clear cornea. In the case of Fuchs' dystrophy the endothelial cells also start secreting material that makes Descemet's layer thicker and more opaque. Vision eventually deteriorates to a point where these patients feel like they are looking through wax paper. Such patients are good candidates for the DSAEK procedure.

Cornea transplantation is a day surgery and can be done either with local, or general anesthesia (for the young or anxious patient).

Pterygium Surgery

Pterygiums are growths on the surface of the eye. They grow toward the middle of the eye over the colored part of the eye. Ptergiums can cause redness, decreased vision, double vision and can rarely become malignant. Removed inadequately, they can recur in at least 50% of cases. With our surgical technique, we have not had a recurrence in over 20 years managing these cases.

Pterygium surgery is a day surgery under local anesthesia with sedation.

Eye Surface Cancer

There are different types of eye surface cancers and pre-cancer. The most common is called Squamous Neoplasia. These can present with a focal area of redness at the junction of the white and colored part of the eye, or as a translucent sheet growing onto the cornea.

Dr. Maskin has discovered and published a cure in the Peer Review Literature in 1994 for this type of neoplasia. This landmark contribution to Ophthalmology was printed in the Chinese and Spanish editions of Archives of Ophthalmology.

Ocular Surface Research & Education Foundation, Inc.(OSREF)

OSREF is a tax exempt non-profit foundation whose mission is to conduct research and to develop therapies to relieve the suffering of patients with ocular surface and tear disorders. Dr. Maskin serves on the board of directors and is co-researcher.