Punctal Plug

Key points at a glance

Key points of this disease

• Punctal plugs are small devices that close the tear drainage system to prolong tear retention on the ocular surface.
• They are mainly indicated for aqueous-deficient dry eye that does not respond adequately to eye drops.
• Silicone types (Super Eagle™ Plug, Punctal Plug® F) and atelocollagen types (Keeptear®) are used in Japan.
• Insertion is a minimally invasive outpatient procedure, and the effect is noticeable immediately.
• Complications include dislodgement, migration, granulation, and epiphora, but serious ones are rare.
• About half spontaneously fall out within an average of 1.5 years, so regular check-ups are needed.

1. What are Punctal Plugs?

Punctal plugs are small medical devices that close the tear drainage system to increase tear volume and retention time on the ocular surface. After being secreted by the lacrimal gland, tears drain through the puncta located at the inner edges of the upper and lower eyelids, then through the canaliculi, lacrimal sac, and nasolacrimal duct into the nasal cavity. Punctal plugs block this drainage pathway, essentially acting like a stopper to retain tears.

They are widely used as an adjunct to topical eye drops in the treatment of dry eye and various ocular surface diseases.

Classification

Lacrimal occlusion devices are classified by insertion site and material.

Punctal Plugs

Insertion site: Placed in the punctum.

Visibility: Easily visible and removable with a slit lamp microscope.

Features: Low risk of deep migration but slightly higher risk of dislodgement.

Canalicular Plug

Insertion site: Inserted into the vertical or horizontal canaliculus.

Visibility: Somewhat difficult to locate and retrieve.

Features: Low risk of dislodgement, but risk of deep migration.

Classification by Material

• Silicone type: Provides long-term occlusion. In Japan, the SuperEagle™ Plug (Eagle Vision) and Punctal Plug® F (FCI) are mainly used.
• Atelocollagen type (Keeptear®): Liquid at 2–10°C, becomes a white gel near body temperature. Easy insertion without punctal sizing or dilation, but effect lasts about 2 months, shorter than silicone type.
• Thermosensitive acrylic type (SmartPlug): Shortens and expands within the canaliculus as temperature rises, achieving a custom fit.
• Absorbable hydrogel type (Form Fit): Swells and becomes gelatinous upon contact with tears.
• Collagen type: For temporary occlusion. Dissolves within 1–2 weeks after insertion. Used as a trial before permanent occlusion.

Q What types of punctal plugs are available?

A

Broadly, there are silicone types (long-term use) and atelocollagen types (liquid plug, lasting about 2 months). Silicone types are divided into punctal plugs placed at the punctum and canalicular plugs inserted into the canaliculus. It is common to perform a trial with a temporary collagen plug before permanent plug placement.

2. Indications and Patient Selection

Main Indications

The basic indication for punctal plugs is dry eye cases where symptom improvement with eye drops is insufficient.

• Aqueous-deficient dry eye: Dry eye associated with Sjögren’s syndrome (SS), graft-versus-host disease (GVHD), and Stevens-Johnson syndrome (SJS) is particularly well-suited for punctal plugs.
• Severe dry eye with corneal filaments
• Superior limbic keratoconjunctivitis
• Acquired punctal stenosis: Maintain tear flow with fenestrated punctal plugs.
• Prolongation of ocular surface retention time of topical medications: Enhancing the efficacy of glaucoma medications, etc.

Role in Dry Eye Treatment

Based on the TFOT (Tear Film Oriented Therapy) concept advocated by the Japanese Dry Eye Society, the treatment strategy is determined by diagnosing which layer of the tear film is abnormal. In severe aqueous-deficient dry eye (area break), punctal plugs are indicated when eye drops (artificial tears, sodium hyaluronate, diquafosol sodium, rebamipide) alone cannot ensure sufficient moisture.

A Cochrane review (18 RCTs) did not reach a definitive conclusion regarding improvement of dry eye symptoms and signs with punctal plugs. There was variability in plug types, DED subtypes, and severity, and standardized testing methods were lacking¹⁾.

Prevention and Daily Care

After punctal plug insertion, it is recommended to continue using artificial tears or sodium hyaluronate eye drops. Avoid rubbing the punctal area vigorously; face washing can be done as usual. Regular eye examinations should be performed to check for complications. In short BUT-type dry eye, punctal plugs may have limited efficacy, so eye drops that promote mucin secretion, such as Diquas® or Mucosta®, may be effective.

3. Insertion Technique

Pre-Insertion Preparation

Punctal plug insertion can be performed under a slit lamp microscope in an outpatient setting. If a stable position cannot be maintained or when inserting into the upper punctum, a supine position is recommended.

Information to explain to the patient:

• Tearing and blurred vision may occur (especially caution in short BUT-type dry eye).
• Increased eye discharge
• Foreign body sensation from the plug
• Possibility of spontaneous loss (approximately half fall out within an average of 1.5 years)
• Complications (punctal swelling/enlargement, fistula, etc.)

Procedure

1. Gauging: Measure the punctal diameter using a punctal gauge (e.g., Eagle Vision plug gauge, Otaka-style plug gauge). The average punctal diameter is 0.5–0.8 mm, and the upper punctum tends to be smaller than the lower punctum. Punctal Plug® F is a one-size design, so measurement is unnecessary.
2. Punctal dilation: If necessary, dilate the punctum with a punctal dilator. Some plugs come with a dilator on the opposite side of the pre-loaded inserter.
3. Insertion: Insert the plug into the punctum using an inserter. For the lower punctum, pull the lower eyelid downward and outward; for the upper punctum, evert the upper eyelid and pull upward and outward. Confirm that the entire plug is not buried in the punctum, then press the handle to deploy.

Forcibly inserting a plug larger than the punctal diameter risks migration into the lacrimal duct, while a plug that is too small may repeatedly fall out. Proper size selection is important.

Filling with liquid plug (KeepTear®)

KeepTear® is filled using a method similar to lacrimal irrigation. Insert the injection needle about halfway into the canaliculus and inject into both the upper and lower puncta. Be careful not to insert the needle too deeply, as it may enter the lacrimal sac and fail to achieve occlusion. After injection, close the eyelids and apply a hot pack for 10–15 minutes to promote gelation. Avoid excessive heating, as temperatures above 40°C may cause the gel to reliquefy and lose its effect.

Removal

Punctal plugs can be easily removed with forceps. If the plug has migrated deeper, perform pressurized irrigation with saline. Removal of a canalicular plug complicated by canaliculitis or granuloma may require canaliculotomy.

4. Treatment Efficacy

The increase in tear volume after punctal plug insertion is immediately noticeable. If there is no improvement in the tear meniscus at the one-week follow-up, the effect is considered insufficient.

Treatment often begins with insertion into only one punctum; if the effect is insufficient, insertion into both upper and lower puncta is considered.

According to TFOS DEWS III, punctal plugs are positioned as an interventional treatment for moderate to severe aqueous-deficient dry eye. In a prospective study of 30 patients who received non-absorbable punctal plugs in both lower puncta, tear proteins such as glutathione synthetase and IL-1 were upregulated after 3 weeks ¹⁾.

Precautions and side effects in treatment

In cases of short tear break-up time dry eye where tear volume is not necessarily reduced, punctal plug insertion may easily cause epiphora, so caution is needed. Also, repeated plug loss can enlarge the punctum, making it difficult to fit a plug. In such cases, permanent closure by punctal cautery (/cornea/punctal-cauterization/) is considered.

Q How much does a punctal plug cost?

A

Under Japan’s medical fee schedule, “K200-2 Punctal plug insertion / Punctal closure (760 points)” applies. It is billed only once, even if performed on both upper and lower puncta. The material cost for a punctal plug is 393 points per punctum. For insertion into all four puncta of both eyes, the total is 3,092 points (approximately 9,300 yen with 30% co-payment).

5. Complications

Serious complications from punctal plugs are rare, but the following have been reported ¹⁾.

• Spontaneous loss: The most frequent complication. Reports indicate that about half are lost within an average of 1.5 years.
• Plug migration: The plug falls into the lacrimal canaliculus. Improved designs have reduced this, but caution is still needed.
• Epiphora: Due to excessive tear retention. It can be prevented by confirming with a trial insertion.
• Granulation formation: Inflammatory reaction around the plug. Managed with steroid eye drops; if it does not resolve, the plug is removed.
• Punctal enlargement: Repeated loss and reinsertion enlarge the punctum, making it difficult to fit a plug.
• Canaliculitis / Dacryocystitis: Rare. The plug is removed and systemic antibiotics are administered.
• Corneal epithelial damage: Due to contact with the plug.

If complications occur, first remove the plug. For granulation tissue, if punctal occlusion is desired, observe; if resolution is desired, use steroid eye drops.

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6. Latest Research and Future Prospects (Investigational Reports)

For Patients: Please Read Carefully

The following content is currently under investigation or in clinical trials and is not standard treatment available at general hospitals. It is reference information for professionals regarding future medical developments.

3D-Printed Punctal Plugs

Khanna et al. designed a punctal plug with an integrated drug delivery system using open-source 3D design software (FreeCAD) and fabricated it with an LCD 3D printer. The hollow cylindrical portion can store medication, allowing customization to each patient’s punctal diameter ²⁾.

Currently, the material used is resin (non-biocompatible), so clinical use is not possible. However, future development of punctal plugs using biocompatible materials such as polyethylene glycol (PEG) is planned ²⁾.

Punctal Plugs as Drug Delivery Platforms

As a countermeasure to poor adherence to eye drop therapy (non-adherence rate approximately 40%), research on sustained drug delivery systems is advancing. Prostaglandin-containing punctal plugs are being considered as an alternative to eye drop therapy for glaucoma and ocular hypertension.

Q Are punctal plugs used permanently?

A

Silicone-type punctal plugs are intended for long-term use, but spontaneous loss can occur, so they are not permanent. If lost, reinsertion is possible. If retention is difficult and repeated loss occurs, permanent closure via punctal cautery may be considered. Collagen-type plugs are temporary, with effects lasting 1-2 weeks, and atelocollagen-type plugs last about 2 months.

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7. References

1. TFOS DEWS III Management and Therapy Report. Am J Ophthalmol. 2025.
2. Khanna T, Akkara JD, Bawa V, Sargunam EA. Designing and making an open source, 3D-printed, punctal plug with drug delivery system. Indian J Ophthalmol. 2023;71:297-299.
3. Comez AT, Karakilic AV, Yildiz A. Silicone perforated punctal plugs for the treatment of punctal stenosis. Arq Bras Oftalmol. 2019;82(5):394-399. PMID: 31271571.