What is Tear Duct Occluder TM for?
Tear Duct OccluderTM is for any patients who use eyedrops. It prevents eyedrops drain through the nasolacrimal ducts into the throat causing drug side effects, ranging from unpleasant bitter taste in the mouth to more serious adverse effects, such as low blood pressure, reduced pulse rate, fatigue, and depression. Some eyedrop medications need prolonged contact time in the eye in order to be effective. This device wlll keep the eyedrop in your eye so that the medications may infuse into your eye fully and not partially drain away through the tear duct into the throat. This device is primarily for glaucoma patients because glaucoma eyedrops require long contact time in the eye and have relatively serious side effects, if leaking into your throat through tear ducts.
If you use dry-eye eyedrops, such as Xiidra, this device can prevent you getting dysgeusia (bad aftertaste) following your eyedrop instillation.
Wear Tear Duct OccluderTM before you instill the eyedrops and continue to wear it for 5 minutes. Repeat the process for the next eyedrops, if any.
Tear Duct OccluderTM is a prescription medical device that has to be prescribed by a licensed eye care professional, such as ophthalmologist, optometrist or optician. This device is flexible and bendable by hand to fit any size and any shape of adult facial contour along the nasal aspect of your orbital rim. Your doctor will fit the device on you and teach you how to readjust it at home, as needed. As part of your eye examination, your doctor will perform a dye disappearance test to verify if Tear Duct OccluderTM fits you and will occlude (or block) your tear ducts properly.
Direction of Use
- Put on Tear Duct Occluder. (If it does not fit, see adjustment procedure below.)
- Pull the lower eyelid down to form a pocket to receive eyedrops.
- Put eyedrops into the eyelid pocket by aiming at the center of the eye.
- Wait for 5 minutes and then remove the device or repeat Steps 2 and 3 for next eyedrops.
Always put on Tear Duct Occluder before put in eyedrops!
Eyedrops are like excessive tears that naturally drain through the tear ducts into the throat. If your doctor advised you that you need to press your tear duct (i.e. to perform tear duct occlusion) while applying eyedrops, then the eyedrops you are using may require long retention time to be adsorbed into your eyes fully and/or it might have bad side effects on the other parts of your body. Therefore, the delivery of medication will improve if you perform tear duct occlusion following eyedrops instillation. Tear Duct OccluderTM offers you an easy way to perform tear duct occlusion to keep the eyedrops in your eyes and/or prevent systemic side effects.
In general, the benefits of performing NOL following eyedrops instillation are:
- Improve intraocular absorption with increased surface contact time.
- May avoid additional glaucoma medications or surgery at the discretion of your ophthalmologist.
- Reduce systemic side effects, such as low blood pressure, reduced pulse rate, fatigue and depression caused by beta blockers type of eyedrops.
- Prevent the bitter aftertaste from certain eyedrops.
There is strong scientific proof that nasolacrimal occlusion following eye drop instillation improves delivery of medication. Prior clinical studies (Study A, Study B) show that the efficacy of applying punctal occlusion in lowering glaucoma patient’s intraocular pressure (IOP) is about 2 mm Hg. For more detailed safety and effective information, please see Tear Duct Occluder Labeling.
Tear Duct OccluderTM is indicated to temporarily occlude the ducts in adult patients to reduce outflow through the nasolacrimal ducts. It is a prescription device and must be prescribed by a licensed eye care professional.
Tear Duct OccluderTM has the “look and feel” of a spectacle frame. It is made up of flexible material that is rigid enough to maintain the shape of the frame during normal use (but not too rigid to hurt the facial tissue) yet soft enough to bend by hand. This material characteristic enables this device be fully adjustable to fit individual patients. The skin contact portions of the frame are covered with silicone rubber (i.e. Latex-free) to improve comfort and increase coverage over the tear ducts.
Safety & Effectiveness
Use Tear Duct OccluderTM for 5 minutes at a time. You should consult a licensed eye care professional with regard to the use of this device, in case of open globe, post-surgery, infection, and inflammation. You are advised to stop using this device should the skin, in contact with the device, develop irritation. This device should not be used if you use anti-coagulants. For additional safety information, please see Tear Duct Occluder Labeling.
The effectiveness of performing nasolacrimal occlusion depends on the fitting of the device on you. Proper fitting is to be verified by a licensed eye care professional via the Simplified Dye Disappearance Test as described in Tear Duct Occluder Labeling. FDA has approved this device as safe and effective for temporarily occluding the nasolacrimal ducts in adult patients to reduce outflow through the tear ducts.
Tear Duct Occluder, as its name implies, is for occluding tear ducts. Unlike punctal plugs, it occludes the tear ducts via compressing the tear ducts externally. In the past, doctors used to adjust the device frame to conform to patient’s facial contour at the nasal aspect of the orbital rims.
Now, after an extensive clinical trials and research we have developed a new device shape that fits almost anyone of any races with minimal or no adjustments. The minimal adjustment means squeezing or widening the space between two nose pads to fit the nose. No other multi-dimensional adjustments required. The adjustment is to be done by patients, not by doctors.
This new device is precisely fabricated via a computerized machine to assure a perfect fit to your nasal aspect of your orbital rim. So far, all mail order patients took it out of the box and use it without needing any adjustment. In case it does not fit you, the following adjustment procedures should be followed.
If you had been routinely practicing manual NLO before, than by switching to Tear Duct Occluder should not change your IOP reading if the fitting is correct. If you have never practiced manual NLO or did not practice it consistently, then Tear Duct Occluder should lower your IOP reading.
At home, you may experience bitter aftertaste at your throat immediately after instilling your particular eyedrops. If so, then either the device was not fit correctly or the Velcro strap around your head was not fastened enough. The device frame is flexible and bendable by hand. You can readjust the device and/or tighten the Velcro strap at home and then utilize this bitter aftertaste to check the nasolacrimal occlusion effect. However, you may ask your doctor to check your device fitting in your follow-up visits.
For additional adjustment information, please see TearDuctOccluder User Instruction.
Over time, the nose pad sleeves may be coated with some deposit. This layer of deposit may or may not be visible. It is advisable to clean it weekly with an alcohol patch or moistened facial tissue. The service life of this device is expected to be 6 months or when the Velcro fabric becomes loose or shows signs of wear and tear, whichever comes first.
The Tear Duct OccluderTM should be placed on an open surface or hung on the wall with no objects pressing against it.
The Velcro strap of the device typically begins to loosen after 6 months of use. Depending on the number of times the device is used, the failure time may be longer or shorter than 6 months. The failure mode is when the Velcro fabric shows sign of wear and tear.
The Tear Duct OccluderTM does not contain hazardous materials and may be disposed as household trash.
Troubleshooting & remedies for adverse effects
Feel pressure pain while wearing the device.
This may be caused by the following reasons.
1. Check the dimension of the device: the upper and lower distances between two nose pads. The upper distance is the distance across the nose by the corners of your eyes. The lower distance is the distance across the lower part of your nose bone. The upper distance should tug snugly against the upper nose bone . The lower distance should be loosely touch the lower nose bone.
2. Check the Velcro strap tightness. Only a gentle pressure is needed to occlude the tear ducts. Loosen the Velcro strap may solve the problem.
3. If loosen the Velcro strp does not solve the problem, check the nosepad curvature. If it curves more than your face contour, it could yield uneven pressure causing pain. The picture on the right illustrates the case.
The nosepad in red color has a deep curvature and the red arrows represent the uneven force exerted on the nasal aspect of the orbital rim. If you bend the nose pad slightly to curve less as indicated by the nose pad in black color, the force exerted on the nasal aspect of the orbital rim become more even and you will no longer feel the pain. Please readjust the fitting according to Tear Duct OccluderTM user Instructions or return the device to your licensed eye care professional for refitting and confirmation that the device is functional via the simplified dye disappearance test described on the Physicians Page. If the problem persists, do not give up, call Tear Duct Occluder Support at 508-259-5200 or email: firstname.lastname@example.org
Feel pinch at the corner of the eyes when wearing the device.
This is because the nose pads were set apart too much that reached the corner of the eyes. The remedy is to push both nose pads closer to the nose.
Feel uncomfortable while temples press around the ears.
This problem can be resolved by flip the temple hook upwards.
Temple hook slips out of temple sleeve.
Clean the hook with soap to remove any grease and then reinsert the hook back into the temple sleeve.
Velcro straps pulling woman’s heir.
The pulling of heir is cause by the Velcro loop tape near the temple hook area. The remedy is the wrap some cloth of tape around the area. This problem did not occur on male patients.