Round table: Board members address Cyclogyl shortage, pediatric myopia
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Cyclopentolate is a key ingredient in Cyclogyl, an ophthalmic solution used for cycloplegic refraction during an eye examination. It is also currently in short supply, according to the FDA.
OSN Pediatrics/Strabismus Board Members, led by Section Editor Robert S. Gold, MD, discussed their experiences dealing with the shortage, as well as other topics, in a virtual round table.
Source: South Georgia/North Florida Eye Partners, PC
Robert S. Gold, MD: There is a real shortage of Cyclogyl right now. For us, as pediatric ophthalmologists, that means that doing cycloplegic refractions is going to become more challenging. We have been trying to order 1% and 2% Cyclogyl, and at the moment, some of our major vendors cannot even get it. Even if you do get it, it is in the small 2 mL bottles, and you do not even have enough to mix it with Mydriacyl (tropicamide ophthalmic solution) and phenylephrine. On top of that, the cost is astronomical. It is almost like during the pandemic when you needed toilet paper or hand sanitizer. In our office right now, we are in a panic. We are going to have to go to some form of Mydriacyl/Neo-Synephrine combination.
Roundtable Participants
-
Moderator
- Robert S. Gold
- Anthony P. Johnson
- Courtney L. Kraus
- Erin D. Stahl
- Rudolph S. Wagner
- Roberto Warman
- M. Edward Wilson
Rudolph S. Wagner, MD: Some clinics in hospitals require using one bottle for one patient. That complicates things, especially for a drug such as Cyclogyl. We have had a waiver to allow the compounding pharmacy to mix the drops to make a combination of Cyclogyl, Mydriacyl and phenylephrine, which we have been using for years. In the past 6 months, the pharmacy has noted a shortage in Cyclogyl, and we are substituting with Cyclomydril (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution), but it does not seem to work for cycloplegic refractions. You get adequate dilation and probably cycloplegia if you wait long enough when we do our retinopathy of prematurity examinations, but not in older children. I am not sure where the shortage came from, but it is an issue. It can be hard to do cycloplegic retinoscopy, especially when looking for maximum hypermetropia in accommodative esotropia patients, if you are not using higher concentration of Cyclogyl in the combination drops.
M. Edward Wilson, MD: I have not heard much about a shortage. Our compounding pharmacy makes up our mixture, and the pharmacists have not mentioned anything. Our pharmacy supplies us with the mixture in small aliquots, and so far, it has not communicated with us that it is running out. The pharmacy can take a bottle and make it last a long time.
Gold: I have tried to contact some of the compounding pharmacies that are part of the listservs, and they are not even answering my emails. I assume that they are getting bombarded by private practitioners.
Anthony P. Johnson, MD: I am going to be the outlier. I had a scary experience with a 2-month-old with a mixed combination of Mydriacyl, Cyclogyl and Neo-Synephrine about 10 years ago, and I decided that I was going to see how things worked out with no Cyclogyl. I have not used it in 10 years, and I do not think it has made a difference. I think one of the biggest sources of the shortage is the one-bottle-one-patient policy at some outpatient hospitals that was mentioned earlier. You are already struggling with limited supply, and you just waste it. I think that is more rampant than anybody realizes.
But clinically, I have not noticed a Cyclogyl shortage because I do not use it. Using a different mix may be a solution. I take three 15 mL bottles of tropicamide and split a 5 mL of 10% Neo-Synephrine between them. That winds up being about 0.9% tropicamide and 2% Neo-Synephrine.
Gold: We also use Cyclomydril for infants with ROP, but it is such a dilute amount of Cyclogyl that I would almost rather use the full-strength Mydriacyl than that. Plus, the bottle of Cyclomydril costs a lot of money. As a private practitioner, it is about $70 per bottle.
Roberto Warman, MD: We ordered a lot of the 2 mL Cyclogyl and were able to mix them up. I think we have about a 6-month supply by having done that, but this has to be solved. If not, we will be using tropicamide. The only problem with that is you have to get the patient in within 20 minutes or so because, if not, you are going to start having problems.
Wilson: One thing I think we should remember is that retinoscopy is actually more accurate with a smaller pupil — 3.5 mm is the ideal pupil size for retinoscopy. If you have a big pupil, you see the retina well, but it may decrease your retinoscopy accuracy because you get a lot of peripheral false retinoscopic reflexes. If you are good at dry refraction and you are good at controlling where the child is accommodating and fixating to, I would try that. I teach a lot of dry retinoscopy because, while I dilate and cycloplege when I need to, it wastes a lot of time, so it is very useful to be good at doing dry retinoscopy in children.
Maybe we would have to go back to atropine refractions for accommodative esotropia patients, but I do a lot of dry refractions during follow-up even in these children. In many children, the drops we are talking about are for viewing the retina and do not necessarily improve retinoscopy. Therefore, Mydriacyl and Neo-Synephrine may work for many patients even without cyclopentolate.
Warman: This is similar to a shortage we had before with atropine 1%. It has gotten a bit better, but 6 months ago, there was difficultly getting the 1%, maybe because everyone was ordering diluted compound pharmacy atropine. The companies are going to have to get their acts together. These are not difficult medications to produce.
Myopia
The prevalence of myopia is rising, with 41.6% of Americans having the condition. That figure has doubled in the last 50 years, according to the American Academy of Ophthalmology. The greatest concern is among individuals with high myopia, which can lead to severe conditions such as glaucoma and retinal detachment.
During the round table, the board members discussed treatments that can be implemented in childhood to help slow the progression of myopia before it reaches a severe stage.
Gold: I want to know what you are currently doing in your practice for myopia. What age are you starting, and how long are you treating patients? Are you doing refractive surgery or using corrective lenses? What kind of atropine are you using?
Erin D. Stahl, MD: All myopia control within our practice is done by optometrists. Right now, there are about five pediatric ophthalmologists for our 2 million population. There is no way we could see kids for myopia control. So, we use optometrists within our practice to do that. They use orthokeratology (ortho-K), MiSight (CooperVision) and some of the other contact lenses. They also use dilute atropine. I trust them with their protocols, which are always evolving.
Warman: I have been using atropine 0.01% for 3.5 years, and I am happy with it. My main problem has been the percentage of patients who drop out. It is not a small percent. I think at one point it was as high as 30%. Now that more information is out there, I think people are staying with it more.
Since the LAMP study came out, I have been starting more patients at 0.05%. It is a little early to have data, but if I get a kid who is young, the 0.05% is what I am using. I had one patient who complained that the pupil was too dilated in the morning, but after a couple of weeks, they got used to it. If I get a 13-year-old and I want to put them on atropine, I still use the 0.01% based on the data of the original study.
I have also started using MiSight. I think I have enrolled six or seven patients, and I have enrolled two more just in the last few weeks. Interest in these lenses is only going to increase. I have patients who have been asking me about defocus glasses. There are also Hoya glasses, which are not in the United States yet but are available in Canada. We are going to be seeing all types of things, and we will not have a good grip of what is better for quite some time.
Courtney L. Kraus, MD: My percentages do not differ too much from what Roberto described. I start almost everybody on the 0.01%. From there, I go up if they are progressing. I see these patients every 6 months. I usually obtain axial lengths annually, and I perform cycloplegic refractions any time they have a drop in acuity or once a year if their vision remains 20/20 — or whatever their best on-record visual acuity is.
I have not had much patient drop-off, but most of my myopia practice is in my Bethesda, Maryland-based, suburban practice, and I feel like I have a highly educated, highly motivated parent population that comes in to ask me about atropine. One of my main talking points is that the only negative I can provide is about how long to stay on the drop and compliance. Most of these parents try to advocate that they will be active participants right from the get-go. From that aspect, I think they sort of self-select.
We also have optometrists who do all of our MiSight patients, and they have been using that to a limited extent. I do not think any of our optometrists use ortho-K, but some people in the community do, and I am able to co-manage with them.
Gold: In my practice, when I mention how long some of the treatments are going to be, that scares people away even though there are a lot of benefits. That has been my problem.
Wagner: I do not aggressively recruit patients to start this treatment. People frequently come in well educated about it and ask about it. Those are the people who are going to be more compliant and willing to accept the expense of the drops.
Warman: How early is too early to start atropine? I did not use to give it to anybody younger than 4 years. Now, I have kids as young as 2 or 3 years old. Some are post-laser ROP, and some are just high myopes. I do not know if it is correct to start them on atropine at age 2 years. I have one that I did, but it is a tough decision. I am talking kids who are –7 D or –9 D, at least, at age 2 years.
Wagner: I like to start patients when they are younger if I can document the progression of myopia, especially when there is a family history in both parents. If a patient is +0.5 D and comes back a year later at –0.5 D, I believe the treatment might be of greater benefit. It makes sense if there are lesser degrees of myopia to begin with. As for what age to start, I have not used low-dose atropine in anyone younger than 3 or 4 years.
Johnson: As others have said about these younger patients who are myopic, sometimes they are post-laser, and sometimes they are syndromic. However, sometimes they are just normal kids who are myopic at a young age. In my experience, they do not necessarily behave the same with progression of myopia as they grow, and they sort of just stay within a diopter or so for several years. I do not know what the benefit of atropine is in these kids. At the same time, you do not know for sure when you are making a decision at age 2 or 3 years. I do not think anyone can be criticized for saying, “Let’s do what we can to see if we can’t keep this from becoming any greater.”
I do not think there is a huge benefit if you can keep a patient from going from –2 D to –4 D. I do not think the statistics for detachments are exponentially greater between –2 D and –4 D, but in that particular example, they will still need correction. If you can keep them from becoming myopic or less than a diopter of myopia by starting early, that seems like what would be a real world-beater if we could be confident in doing that.
Wilson: The goal of myopia prevention is to prevent high myopia and the blinding complications of high myopia. I do not think the goal is to make a –4 D a –2 D. The struggle has been in predicting who is at the highest risk for becoming a high myope and trying to mitigate that risk. The age at which you start is going to be different for someone who becomes myopic at an earlier age vs. a later age. Whether you treat it yourself or someone on your team treats it, we all need to be educated about all the options to reduce myopia progression. This is a big tidal wave that is coming, and it is almost here. All of us who practice pediatric ophthalmology are obligated to be able to have a conversation with our patients about myopia prevention options.
- References:
- American Academy of Ophthalmology leads global initiative to address worldwide myopia epidemic. www.aao.org/newsroom/news-releases/detail/academy-leads-initiative-to-address-myopia. Published Nov. 11, 2020.
- Current and resolved drug shortages and discontinuations reports to the FDA. www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Cyclopentolate+Ophthalmic+Solution&st=c&tab=tabs-3&i=15&panel=15. Accessed July 7, 2021.
- For more information:
- Robert S. Gold, MD, can be reached at 790 Concourse Parkway South, Suite 200, Maitland, FL 32751; email: rsgeye@gmail.com.
- Anthony P. Johnson, MD, can be reached at South Georgia|North Florida Eye Partners, 4120-A North Valdosta Road, Valdosta, GA 31602; email: anthonyjohnsonmd@gmail.com.
- Courtney L. Kraus, MD, can be reached at Wilmer Eye Institute, 615 N. Wolfe St., Wilmer 230, Baltimore, MD 21205 email: ckraus6@jhmi.edu.
- Erin D. Stahl, MD, can be reached at Children’s Mercy Hospitals and Clinics, 2401 Gillham Road, Kansas City, MO 64108; email: edstahl@cmh.edu.
- Rudolph S. Wagner, MD, can be reached at Doctors Office Center, Suite 6100, P.O. Box 1709, Newark, NJ 07101; email: wagdoc@comcast.net.
- Roberto Warman, MD, can be reached at Miami Children’s Hospital, 3200 SW 60th Court, Suite 103, Miami, FL 33155; email: rwarman@eyes4kids.com.
- M. Edward Wilson, MD, can be reached at Albert Florens Storm Eye Institute, 167 Ashley Ave., Charleston, SC 29425; email: wilsonme@musc.edu.
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