Safety of Punctal Plugs: one of the best treatments for dry eyes that is covered by most insurances

Punctal Plugs are generally very safe. Punctal Plugs got a bad wrap when one called the Smart Plug caused some issues with infections around the puncta and canal, called canaliculitis or dacrocystitis. That was around 2006.

The newer version of Punctal Plugs is much safer. I have never had a complication from the plugs we use.

More information about punctal plugs is located on my previous post:

https://eyedoc2020.blogspot.com/2018/01/which-is-best-punctal-plug.html

Ophthalmology. 2006 Oct;113(10):1859.e1-6. Epub 2006 Aug 22.

Management of complications after insertion of the SmartPlug punctal plug: a study of 28 patients.

SmartPlug Study Group.

Abstract

PURPOSE:

To characterize and describe the management of complications seen in patients who have undergone insertion of the SmartPlug permanent punctal plug.

DESIGN:

Retrospective case series.

PARTICIPANTS:

Patients who experienced complications after SmartPlug insertion and were treated by 1 of 18 ophthalmic plastic and reconstructive surgeons between January 2004 and October 2005.

METHODS:

Presenting symptoms and signs and the management of complications were analyzed.

MAIN OUTCOME MEASURES:

Prevalences of canaliculitis and dacryocystitis, tearing at presentation, and outcome of conservative and/or surgical management of the SmartPlug complications.

RESULTS:

Twenty-eight patients were included in the study; 13 had bilateral involvement. On initial presentation, 18 patients had inflammation, including 17 with canaliculitis and 1 with recurrent acute dacryocystitis. Ten patients had little or no inflammation; all 10 had tearing of the involved eye(s). In 5 patients, complications resolved after office irrigation of the lacrimal drainage system; in a sixth patient, silicone intubation was performed as well. Canaliculotomy was performed in 13 patients (bilateral in 3) and combined with silicone intubation (3 patients). Canaliculotomy was planned in an additional 2 patients. Canaliculitis in 1 patient responded to a course of oral antibiotics; the plug was massaged out of the punctum in a retrograde fashion in another patient. In still another patient, the plugs expressed themselves at the time of planned canaliculotomy. In 4 patients, dacryocystorhinostomy (DCR) with silicone intubation was necessary. Two additional patients refused further treatment including DCR and canaliculotomy; both were lost to follow-up.

CONCLUSIONS:

Canaliculitis, acute dacryocystitis, and tearing may be seen in patients who have had SmartPlugs and may be managed by removal of the plug. A trial of topical and oral broad-spectrum antibiotics followed by retrograde massage of the plug through the canaliculus may be helpful should plug removal be deemed appropriate. If conservative measures fail, canaliculotomy with removal of the plug may be considered; DCR may be necessary. Although lacrimal irrigation may resolve the problem, irrigation also may dislodge the plug from its canalicular position and cause permanent obstruction of the lacrimal drainage system.

Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome A Report by the American Academy of Ophthalmology Marcus M. Marcet, MD,1 Roni M. Shtein, MD, MS,2 Elizabeth A. Bradley, MD,3 Sophie X. Deng, MD, PhD,4 Dale R. Meyer, MD,5 Jurij R. Bilyk, MD,6 Michael T. Yen, MD,7 W. Barry Lee, MD,8 Louise A. Mawn, MD9 Objective: To review the published literature assessing the efficacy and safety of lacrimal drainage system plug insertion for dry eye in adults. Methods: Literature searches of the PubMed and Cochrane Library databases were last conducted on March 9, 2015, without date restrictions and were limited to English language abstracts. The searches retrieved 309 unique citations. The primary authors reviewed the titles and abstracts. Inclusion criteria specified reports that provided original data on plugs for the treatment of dry eyes in at least 25 patients. Fifty-three studies of potential relevance were assigned to full-text review. The 27 studies that met the inclusion criteria underwent data abstraction by the panels. Abstracted data included study characteristics, patient characteristics, plug type, insertion technique, treatment response, and safety information. All studies were observational and rated by a methodologist as level II or III evidence. Results: The plugs included punctal, intracanalicular, and dissolving types. Fifteen studies reported metrics of improvement in dry eye symptoms, ocular-surface status, artificial tear use, contact lens comfort, and tear break-up time. Twenty-five studies included safety data. Plug placement resulted in 50% improvement of symptoms, improvement in ocular-surface health, reduction in artificial tear use, and improved contact lens comfort in patients with dry eye. Serious complications from plugs were infrequent. Plug loss was the most commonly reported problem with punctal plugs, occurring on average in 40% of patients. Overall, among all plug types, approximately 9% of patients experienced epiphora and 10% required removal because of irritation from the plugs. Canaliculitis was the most commonly reported problem for intracanalicular plugs and occurred in approximately 8% of patients. Other complications were reported in less than 4% of patients on average and included tearing, discomfort, pyogenic granuloma, and dacryocystitis. Conclusions: On the basis of level II and III evidence in these studies, plugs improve the signs and symptoms of moderate dry eye that are not improved with topical lubrication, and they are well tolerated. There are no level I studies that describe the efficacy or safety of lacrimal drainage system plugs. Ophthalmology 2015;122:1681- 1687 ª 2015 by the American Academy of Ophthalmology.

https://eyedoc2020.blogspot.com/2018/01/which-is-best-punctal-plug.html

Introduction

Dry eye is a common condition that occurs when the eye either does not have enough oil lubrication from the meibomian glands (called Meibomian Gland Dysfunction) and/or the eye's lacrimal gland does not produce enough tears to keep the eye moist, comfortable, pain-free, and give crisp vision. 

When relief from dry eye is not achieved by using warm compresses, cleaning with diluted Tea tree oil or Avenova spray (see video), increased oral Omega 3, artificial tears, or other lubricating products, Dr. Cremers often recommends punctal plugs of the eyelid's puncta or permanent occlusion (if the plugs help but keep falling out). 

A Punctal plug is a tiny devices that occludes the 1 of the 4 puncta or drainage opening of the tear drainage system of the eye, so tears cannot drain into the nose. Punctal plugs are a non-drug procedure for dry eye when artificial tears do not sufficiently decrease dry eye symptoms (burning, redness, foreign body sensation, tearing, itching). This blockage tries to keep your natural tears in your eye longer and improve the quality and quantity of the tear film. One or all 4 openings can be covered or blocked at a time. Doctors often plug both lower eyelids first. If this is not enough, sometimes we will plug the upper puncta as well. If the lower 2 punctal plugs irriate the eye, we will take them out and plug the upper two puncta (or vice versa). 

The most common side effects of occlusion are epiphora (overflow of tears), inhibited tear clearance, and desensitization of the corneal surface, or it does not help symptoms. Very rarely, the plug can lead to an infection in the area of the lacrimal sac or get stuck requiring surgical removal (I have not seen such a case occur but it has been reported).

Punctal Plugs can be classified according:

A. Location of placement:
1. Punctal (at surface of puncta opening)
2. Intracanalicular (deeper into punctal structure)

B. Duration of Placement:
1. Short Duration: Absorbable: made of animal collagen which absorb in about 4-14 days
2. Extended Duration/Semi-Permanent: do not absorb: usually stay in for 2-6 months but have seen them stay in for years. 

C. Punctal plugs can be made out of:

1. Silicone: which are semi-permanent; non-dissolving and may be removed in the future if desired or necessary.

2. Collagen: are temporary
3. Other less commonly used materials:
a. hydrogel
b. polydioxanone
c. acrylic

D. 1 study from Egypt used Botox to cause punctal occlusion after LASIK but not usually done. 

Collagen plugs generally dissolve within four to seven days, while silicone plugs either dislodge spontaneously or are removed by a technician, OD, or MD. 

Surgeons typically prescribe the silicone punctal plugs first unless the patient really wants to try collagen plugs first as the collagen plugs dissolve in a few days (also there are more reports of complications with collagen plugs than silicone plugs as the silicone plugs have a little rim to generally prevent them from falling into the canal too deeply): see below report. 

If the plugs keep falling out, thermal cautery or argon laser achieves permanent occlusion of the puncta.

Punctal occlusion is a permanent (irreversible) alternative to plugs. Should your dry eye symptoms disappear after the temporary or semi-permanent plugs, which keep falling out, you should talk to Dr. Cremers about considering permanent punctal occlusion. If permanent punctal occlusion is considered desirable, the methods most widely used and most effective in producing permanent closure are:

• Electrodesiccation - closing off with electricity 

• Thermal cautery - closing off with heat

• Argon Laser- closing off with Laser: not covered by insurance

 Very occasionally, permanent occlusion may need to be repeated in order to be fully effective. If a patient wants to "undo" the permanent closure, it may require a plastic surgeon to reopen the puncta and canal. 

Similar to punctal occlusion, intracanalicular plugs also block tear drainage, though they act by blocking the canaliculus instead of the punctum so they are pushed further down into the canal.  Most surgeons prefer not to use these as there have been a couple of reports of these causing more risks of infection.

 This is what the inserter looks like: It is about the real size.

 This silicone plug is being placed onto the inserter for placement: it is very small and about the size of the letters "In G" on the dime below. 

There are NO randomized controlled studies to prove one punctal plug is better than the other. Also, given the complexity of the dry eye syndrome and disease, there are no good studies to conclusively prove punctal plugs improve dry eye symptoms for every patient or for even the majority of patients. Still, this procedure is worth a try as it is very low risk and does help patients with their dryness. It may not work for you, but it is worth a try in most patients. It can help prevent the need for using steroid drops for dryness which has the risk of cataract requiring surgery and glaucoma (which is a potentially blinding disease) and is covered by most insurances.

More Information about These Procedures and Permanent Occlusion:

Surgical procedure

Plug insertion is performed in an examination room; it does not require a surgery center. Once you have been checked in and settled comfortably, drops will be used to numb your eye; no injections are needed.

We will ask you to look up and away from your nose. If plugs are being inserted, a forceps-like applicator will be used to place one into the corner of your eye to insert the plug into the orifice of the punctal canal. The entire procedure takes only a few minutes.

The procedure is basically the same for permanent occlusion, only a small injection of anesthesia is given to numb the area. A device is used to seal off (cauterize) the opening and nothing is inserted.

Recovery

Many patients report immediate relief from dry eye symptoms and resume normal activities immediately. Serious complications with punctal occlusion are extremely rare, but like any medical procedure, it does have some risks. If you experience any discomfort with the semi-permanent plugs, Dr. Cremers can easily remove them.

Here is more information about Systemic Reviews of all the data on Punctal Plugs.

Sandra Lora Cremers, MD, FACS


1.

Ophthal Plast Reconstr Surg. 2009 Sep-Oct;25(5):413-4. doi: 10.1097/IOP.0b013e3181b57c01.

Canaliculitis with a papilloma-like mass caused by a temporary punctal plug.

Ahn HB1, Seo JW, Roh MS, Jeong WJ, Park WC, Rho SH.

Author information

Abstract

Absorbable plugs are used before attempting permanent occlusion to observe whether the patient will be amenable to treatment for dry eye. Little is known about the complications of absorbable plugs. The authors present a case of canaliculitis with a papilloma-like mass caused by long-standing unabsorbed collagen plug that had been placed 3 years earlier. This is an uncommon clinical presentation that may be encountered in patients who have canaliculitis symptoms and a history of intracanalicular temporary plug placement.

2. Cochrane Database Syst Rev. 2017 Jun 26;6:CD006775. doi: 10.1002/14651858.CD006775.pub3.

Main results

We included 18 trials (711 participants, 1249 eyes) from Austria, Canada, China, Greece, Japan, Mexico, Netherlands, Turkey, the UK, and the USA in this review. We also identified one ongoing trial. Overall we judged these trials to be at unclear risk of bias because they were poorly reported. We assessed the evidence for eight comparisons.

Five trials compared punctal plugs with no punctal plugs (control). Three of these trials employed a sham treatment and two trials observed the control group. Two trials did not report outcome data relevant to this review. There was very low-certainty evidence on symptomatic improvement. The three trials that reported this outcome used different scales to measure symptoms. In all three trials, there was little or no improvement in symptom scores with punctal plugs compared with no punctal plugs. Low-certainty evidence from one trial suggested less ocular surface staining in the punctal plug group compared with the no punctal plug group however this difference was small and possibly clinically unimportant (mean difference (MD) in fluorescein staining score -1.50 points, 95% CI -1.88 to -1.12; eyes = 61). Similarly there was a small difference in tear film stability with people in the punctal plug group having more stability (MD 1.93 seconds more, 95% CI 0.67 to 3.20; eyes = 28, low-certainty evidence). The number of artificial tear applications was lower in the punctal plug group compared with the no punctal plugs group in one trial (MD -2.70 applications, 95% CI -3.11 to -2.29; eyes = 61, low-certainty evidence). One trial with low-certainty evidence reported little or no difference between the groups in Schirmer scores, but did not report any quantitative data on aqueous tear production. Very low-certainty evidence on adverse events suggested that events occurred reasonably frequently in the punctal plug group and included epiphora, itching, tenderness and swelling of lids with mucous discharge, and plug displacement.

One trial compared punctal plugs with cyclosporine (20 eyes) and one trial compared punctal plugs with oral pilocarpine (55 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.

Five trials compared punctal plugs with artificial tears. In one of the trials punctal plugs was combined with artificial tears and compared with artificial tears alone. There was very low-certainty evidence on symptomatic improvement. Low-certainty evidence of little or no improvement in ocular surface staining comparing punctal plugs with artificial tears (MD right eye 0.10 points higher, 0.56 lower to 0.76 higher, MD left eye 0.60 points higher, 0.10 to 1.10 higher) and low-certainty evidence of little or no difference in aqueous tear production (MD 0.00 mm/5 min, 0.33 lower to 0.33 higher)

Three trials compared punctal plugs in the upper versus the lower puncta, and none of them reported the review outcomes at long-term follow-up. One trial with very low-certainty evidence reported no observed complications, but it was unclear which complications were collected.

One trial compared acrylic punctal plugs with silicone punctal plugs and the trial reported outcomes at approximately 11 weeks of follow-up (36 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.

One trial compared intracanalicular punctal plugs with silicone punctal plugs at three months follow-up (57 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.

Finally, two trials with very low-certainty evidence compared collagen punctal plugs versus silicone punctal plugs (98 eyes). The evidence was judged to be very low-certainty due to a combination of risk of bias and imprecision.

References:

Ervin AM1, Law A, Pucker AD.

(Balaram 2001; Freeman 1975; Willis 1987)

 (AAO 2003; Dohlman 1978; Lemp 1994).
(Barnard 1996; Dohlman 1978; Tai 2002).