Comfort most important when selecting lacrimal plugs

Other decision factors include extrusion rates, range of sizes available, reversibility and safety.

When a surgeon selects a lacrimal plug, the device of choice is the one he or she is most comfortable using, and the one that provides the most comfort for his or her patients. Other factors influencing the choice include external profile, design and sizing options, insertion technique, reversibility, extrusion rate and material. But the prime decision factor remains comfort.

Ocular Surgery News spoke to several ophthalmologists about their criteria for selecting a lacrimal occlusion device. They said they look for a plug that is safe and comfortable for patients.

Those OSN spoke to said they use punctal occlusion as an adjunct therapy for dry eye when more conservative methods fail. They said materials they prefer for the manufacture of lacrimal occlusion device include silicone, collagen and newer acrylic materials. Plugs may be placed near the surface of the lacrimal duct or intracanalicularly.

The surgeons OSN spoke to expressed a wide range of opinions regarding their favorite devices and their reasons for choosing them. Their preferences encompass most of the punctal occlusion devices available today.

Tear Saver, CIBA Vision

Christopher J. Rapuano, MD, a cornea specialist at Wills Eye Hospital in Philadelphia, U.S.A., said his favorite punctal plug is the Tear Saver by CIBA Vision.

"I like the sizes they have. I like the packaging and the exact shape of the plug. They tend to go in reasonably easily and have a low-profile head — the top of the plug. The price is also reasonable," Dr. Rapuano said. "I used to tell patients that 10% of the time I had to take the plug out because they would feel it. Now it’s much lower than that — less than 2%."

Dr. Rapuano said he likes several qualities about the shape of the Tear Saver. The low profile head has been the best improvement in the plug design, he said.

"It seems to have a nice arrow-shaped fit that stays in pretty well. The top part is nice and flat," he said. "The older plugs used to have a sort of dome-shaped head that often poked at the conjunctiva or poked at the eye a little bit. Patients would feel it. The patients hardly ever feel a very flat head."

A common problem he had in using the Tear Saver is that the plugs sometimes fall out, he said. He has not had problems with infection or dacryocystitis.

"We have had problems with plugs falling out, but I’m not convinced one plug is any different from another. I try to put in the biggest plugs that I can fit. If one plug falls out, I’ll put in a bigger plug next time," Dr. Rapuano said.

According to Dr. Rapuano, surgeons must be careful not to snap the head off a plug during plug removal, especially when using larger plugs.

"You have to remember to grab the shaft and not the head when you pull it out," he said.

FlexPlug, Eagle Vision

Users of the FlexPlug by Eagle Vision said size and safety are among the reasons they selected this punctal plug over others.

Norihiko Yokoi, MD, PhD, of Kyoto, Japan, said he uses two of Eagle Vision’s punctal plugs, the EaglePlug and the FlexPlug.

Dr. Yokoi said he prefers the FlexPlug because of its low extrusion rate and low potential for granulation inside of the punctum.

"We always measure the punctum size with a punctum gauge and choose the most appropriate size. We start with the EaglePlug for smaller puncta, and in cases with frequent extrusion we choose larger plugs," Dr. Yokoi said. "The FlexPlug was recently approved here. We expect it to have a lower extrusion rate in smaller puncta."

Kirk Nordwald, MD, of Leipzig, Germany, said he has seen no inflammation or other complications with the FlexPlug. Its safety and longevity are its selling points. He said it is easy to implant, and the variety of sizes allow it to be fit comfortably.

He suggested using a larger plug, although it may be more difficult to insert, so as not to lose the plug into the nasolacrimal duct.

"One problem may be in positioning the plug. Don’t put the plug too far inward. It should end with the skin. If you put it in too deep, then you might lose the plug, so a larger plug is better," Dr. Nordwald said.

Sometimes patients lose the plugs without noticing, but by that time usually their dry eye symptoms have been relieved, he said. Like other surgeons interviewed for this article, Dr. Nordwald uses the plug in combination with lubricating eye drops.

"Sometimes LASIK patients need eye drops every hour. If you insert the FlexPlug and continue using eye drops, the combination therapy is better if you have very dry eyes," Dr. Nordwald said.

The plugs are a permanent treatment option, and when properly sized and instered they are not likely to extrude, according to the manufacturer.

Eagle Vision also makes the Tapered Shaft Flow Controller, a plug that contains a cannula designed to allow drainage when total occlusion is too much.

Herrick Plug, Lacrimedics

The Herrick Lacrimal Plug is an intracanalicular plug. This permanent plug is placed in the horizontal canaliculus for optimum control of drainage, according to the maker, Lacrimedics. The placement of the plug cannot harm the cornea or the nerve endings near the surface of the punctum as some of the other plugs do, the company says. In addition, placement within the canaliculus avoids causing atrophy of the sphincter muscle, which is a possibility the longer a punctal plug is used.

The Herrick Lacrimal Plug is also not easily displaced, contrary to earlier reports that have since been refuted, according to surgeons experienced with the device.

Alan D. Gordon, MD, a general ophthalmologist in private practice in Lewistown, U.S.A., said he uses the Herrick plug most often.

"I’ve had patients feel some of the other plugs that are placed at the surface. Patients don’t feel the Herrick plugs," he said.

Dr. Gordon said the plugs can be irrigated out if it is necessary to remove them.

"It is probably not as easy to take out as other plugs. But the main thing is that there is no foreign body sensation and easy insertion," he said.

Dr. Gordon said he does occasionally have problems with the plugs.

"One of the disadvantages of intracanalicular plugs is that you can’t always be sure it’s in. Sometimes that question comes up. The patient will have more symptoms and you’ll say to yourself ‘I wonder if the plug is in’ because it’s possible it came out. But the plug usually does not come out," he said.

Dr. Gordon said if there is a question about whether the plug is still in place, transillumination can be done to visualize it. If there is still a question, a temporary plug can be put on top of it, and the patient can be checked in 5 days.

Transillumination is easy because of a titanium-based dye used in the plug. Lacrimedics also has 4-mm and 6-mm positioning tools to make sure the plug is inserted past the ampulla, which is known to have nerve endings that can be irritated by a foreign object.

"I’ve also had some patients who have experienced granuloma formation if the edge of the plug is not all the way in the canaliculus, which is easy to manage with a steroid. You also have to reposition the plug. It’s just like any other plug," he said. "I’ve had some patients come in and complain of excessive tearing. That’s probably the most common thing, and it happens in all plugs."

The SmartPlug, Medennium

A newer version of a canalicular plug is the SmartPlug from Medennium. This device is made of a material that is inserted as a tiny rod, 9 mm long and 0.4 mm in diameter. In reaction to body temperature, it expands into a plug in situ in the canaliculus, with a final form 2 mm long and up to 1 mm in diameter.

Christian Spaleck, MD, uses the SmartPlug in Eichstät, Germany. He said he had reservations at first about using a canalicular plug, but he has put these to rest with a study. He monitored patients with the plugs for 3 months and observed no complications, no lost plugs, he said.

"In the beginning I was very cautious and skeptical. When I decided to use these plugs, I removed them in the beginning because I didn’t feel safe with the device completely in the canaliculus. So after 3 months, I removed them through irrigation just to be sure nothing happened to the drainage system," Dr. Spaleck said. "Now, I can leave them since I haven’t seen any plug-related complications."

Dr. Spaleck said he used conventional silicone punctum plugs for years. Disadvantages with these types of plugs include a high extrusion rate and the possibility of irritation to the conjunctiva or cornea. Because of the complications with lacrimal plugs that sit on the punctum, he decided to switch to the newer intracanalicular devices.

"The ideal position of the plug is at the bend from the vertical to the horizontal part of the canaliculus. The plug shouldn’t be brought in all the way when being inserted. It is advisable to leave a small part of the plug, perhaps 2 mm, outside the osteum before it’s activated, and wait for the retraction of the remaining part by activation of the material," he said.

To investigate these devices, he observed 50 patients for 1 year, beginning in May 2001. All patients who received the SmartPlug were evaluated for dry eye and were given a questionnaire on patient satisfaction, he said.

Dry eye symptoms were relieved in nearly all patients, he said. Before receiving the device, all were dependent on artificial tears. After implantation, only 20% still needed some kind of lubricant, Dr. Spaleck said.

"In patients who have had silicone plugs for years, the canaliculus might be enlarged. In these cases, the punctal plug did not stay for long periods of time. If the canaliculus has been dilated by previous silicone plug use, they might not be a good candidate for the SmartPlug," Dr. Spaleck said.

Parasol Punctal Plug, Odyssey

Randy Burks, MD, a plastic and reconstructive surgeon in Fort Lauderdale, U.S.A., said he has found the Parasol Punctal Occluder from Odyssey Medical to be the most comfortable for his patients with dry eye.

As with other lacrimal plugs, the Parasol plug has a dome-shaped head, he said. What differentiates the Parasol from other plugs is a low-profile dome, which does not irritate patients.

In the past, he said, he has used oversized plugs for some patients, which caused irritation. Through experience, he said he can now judge the appropriate plug size for a patient’s punctum and does not use a sizing tool.

"This plug is for patients with low Schirmer test and punctate staining on the cornea," Dr. Burks said. "I noticed tremendous improvement in comfort, and the benefit of the Odyssey Parasol is the little dome that lays on the surface of the eyelid doesn’t irritate. I have them in my own eyes."

Dr. Burks uses Moisture Eyes Protect (Bausch & Lomb) eye drops twice daily for first-line treatment of dry eye. Depending on the severity of the conditions, he may have patients use Genteal Gel (Novartis Ophthalmics), which is a thicker lubricant. He sometimes recommends cyclosporine drops, which must be fabricated by a pharmacy.

When patients complain about having to use eye drops frequently, or if the condition becomes chronic, Dr. Burks then suggests the use of lacrimal plugs, he said.

A subset of patients with dry eye may have puncta that are rotated posteriorly, Dr. Burks said. These patients are unsuitable for the Parasol or any protruding punctal plug that may rub against the eyeball, he said.

UltraPlug, Surgical Specialties

Stephen S. Lane, MD, of the department of ophthalmology at the University of Minnesota, said he has used several brands of punctal plugs, but he prefers the UltraPlug Punctal Plug from Surgical Specialties.

Dr. Lane said he prefers some of the qualities of the UltraPlug material. Although most punctal plugs are similar in using silicone as the plug material, "the stiffness of the material is a little bit different," he said.

The cone-shaped end of the UltraPlug is relatively firm, Dr. Lane said, "so as you are trying to get it through a punctum that is a little smaller in diameter, it’s got a little bit of stiffness, which helps to get it into the orifice."

The UltraPlug is available in five sizes from 0.4 mm through 0.8 mm.

"One of the things I like the most is that the inserter has a very fine tip to dilate the punctum. As a result, you can open the punctum very easily to insert the plug," Dr. Lane said.

The head, which sits on the outside of the opening, on the surface of the lid, is also smooth and conforms nicely to the opening, Dr. Lane said. "So there’s not a lot of extrusion that might rub on the conjunctiva and cause irritation."

When improperly sized, plugs do fall out occasionally, Dr. Lane said. "I would say less than 5% of the time in my usage. I tend to try to oversize them a little bit so they don’t fall out. I also tend to oversize them so you can’t insert them too deeply and lose them in the punctum itself," he said.

"I think it’s not a problem if you put a plug in and it falls out; the patient becomes symptomatic, they come back and you place another plug. There is the potential, however, if you lose one in the canaliculus while placing it, that it could cause potential stagnation and can be difficult to remove. So I tend to oversize them a little bit," he said.

Also available, applicable for longer term use, is the UltraPlug Extended Wear Plug, made of a synthetic absorbable copolymer that lasts longer than collagen plugs, according to the manufacturer. The device is inserted with jeweler’s forceps through the punctal opening into the canaliculus to occlude tear drainage. The company recommends evaluating patients within 2 months of implantation. The plugs are essentially absorbed between 2 and 6 months. The Extended Wear Plug is available in three sizes, from 0.2 mm to 0.4 mm, in standard (2 mm) and short (1.6 mm) lengths.

According to Surgical Specialties, these plugs are an alternative for patients with seasonal allergies or with dry eye after LASIK, and for patients who wear contact lenses. The UltraPlug also can be used after ocular surgery for retention of ocular medications.

Ready-Set Plugs, FCI

Mark Bearman, MD, of Birmingham, U.S.A. has had consistent success with the Ready-Set Punctum Plug from FCI Ophthalmics, and specifically likes the selection of available sizes and the collar at the top the punctum plug that allows for stable positioning and ease of removal, if required.

"I've had great success with the Ready-Set Plugs and have used them for five years," Dr. Bearman told Ocular Surgery News. "I rarely have to use Ready-Set Plugs that are larger than 0.4 mm and 0.6 mm. Another advantage is that these plugs have a flange that keeps the plug well seated in the punctum, which also allows for easy removal." Dr. Bearman said the Ready-Set Plugs can be easily removed by grasp the plug beneath the flange with forceps and pulling the plug out. However, according to Dr. Bearman, these plugs can stay in patients indefinitely and has patients who have had them in for years with no problems.

FCI Ophthalmics' Ready-Set Plugs are designed with an ultra-thin, slanted collarette to conform to the natural anatomy of the eyelid for patient comfort. The plugs are made of a soft medical-grade silicone and come in seven sizes from 0.4 mm to 1 mm. Additionally, the Ready-Set Plugs come preloaded on a disposable inserter/dilator instrument.

"The Ready-Set Plugs come preloaded on an inserter, which is part of the whole package," Dr. Bearman said. "And the inserter has a dilator, with the plug on one end and the dilator on the other, so if you need to open the punctum a bit more, you don't have to reach for a separate instrument."

For Your Information:

• Alan D. Gordon, MD, can be reached at 27 Sandy Lane, Suite 220, Lewistown, PA 17044 U.S.A.; +(1) 717-242-2514; fax: +(1) 717-242-3188.
• Christopher J. Rapuano, MD, can be reached at Wills Eye Hospital, 900 Walnut St., Philadelphia, PA 19107 U.S.A.; +(1) 215-928-3180; fax: +(1) 215-928-3854; e-mail: cjrapuano@hslc.org.
• Randy Burks, MD, FACS, can be reached at Ophthalmology Consultants, The Center for LASIK, 5800 Colonial Drive, Suite 100, Margate, FL 33063 U.S.A.; +(1) 954-977-8770; fax: +(1) 954-977-8774; e-mail: rburks333@aol.com.
• Kirk Nordwald, MD, can be reached at Augen Laser Zentrum – Leipzig AG, Richard-Wagner-Str. 3, 04109 Leipzig, Germany; +(49) 341-7100-46; fax: +(49) 341-7100-484; e-mail: lasik-leipzig@t-online.de.
• Mark Bearman, MD, can be reached at Eastern Ophthalmic Assoc., 52 Medical Park E. Dr. #214, Birmingham, AL 35235 U.S.A.; +(1) 205-838-3050; +(1) 205-838-3814.
• Christian Spaleck, MD, can be reached at Pfahlstr. 27, 85072 Eichstätt, Germany; +(49) 8421-9703-0; fax: +(49) 8421-9703-50; e-mail: augenaerzte@spaleck-schindler.de; Web site: http://www.spaleck-schindler.de.
• Norihiko Yokoi, MD, PhD, can be reached at the department of ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan; fax: +(81) 75-251-5663.
• Stephen S. Lane, MD, can be reached at 280 N. Smith Ave., Suite 840, St. Paul, MN 55102 U.S.A.; +(1) 651-222-5666; fax: +(1) 651-227-9370.

• Odyssey Medical, manufacturer of the Parasol Punctal Plug, can be reached at 5828 Shelby Oaks Drive, Suite 21, Memphis, TN 38134 U.S.A.; +(1) 901-383-7777; fax: +(1) 901-382-2712; e-mail: info@odysseymed.com.
• Medennium Inc., manufacturer of the SmartPlug, can be reached at 15350 Barranca Parkway, Irvine, CA 92618 U.S.A.; +(1) 949-789-9000; fax: +(1) 949-789-9035; e-mail: info@medennium.com.
• Eagle Vision, manufacturer of the FlexPlug, can be reached at 8500 Wolf Lake Drive, Suite 110, P.O. Box 34877, Memphis, TN 38184 U.S.A.; +(1) 901-380-7000; fax: +(1) 901-380-7001; e-mail: info@eaglevis.com.
• FCI Ophthalmics, manufacturer of the Ready-Set Punctum Plugs, can be reached at P.O. Box 465, Marshfield Hills, MA 02051 U.S.A.; +(1) 781-826-9060; fax: +(1) 781-826-9062; e-mail: info@fci-ophthalmics.com.
• Surgical Specialties, manufacturer of the UltraPlug Extended Wear Punctal Plug, can be reached at 100 Dennis Drive, Reading, PA 19606 U.S.A.; +(1) 610-404-1000; fax: +(1) 610-404-4010.
• CIBA Vision Surgical, manufacturer of the Tear Saver Punctum Plug, can be reached at 11460 Johns Creek Parkway, Duluth, GA 30097 U.S.A.; +(1) 678-415-3711; fax: +(1) 678-415-2320.
• Lacrimedics, manufacturer of the Herrick Lacrimal Plug, can be reached at 310 Prune Alley, P.O. Box 1209, Eastsound, WA 98245 U.S.A.; +(1) 360-376-7095; fax: +(1) 360-376-7085; e-mail: info@lacrimedics.com.