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Challenges for emerging technologies in pediatric patients
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The prescription of drugs and medical devices should always be evidence-based and data-driven. With limited information available, it is difficult to popularize the emerging technologies in pediatric ophthalmology.
There are a number of major barriers. For example, the cost of medication for pediatric patients is undoubtedly much higher than that for adult patients. Because the development of drugs is market-driven, with such a small market of patients further divided into smaller age groups, few pharmaceutical companies will bother to conduct clinical trials on pediatric drugs and devices.
Off-label use
One of the challenges pediatric ophthalmologists face is the scarcity of drugs tailor-made for children. Off-label use, therefore, is particularly important to pediatric ophthalmologists, especially when clinical trials conducted in children are often costly with ethical problems, small sample sizes and different responses.
Off-label use is popular in the U.S. and Europe, offering pediatric ophthalmologists a certain degree of flexibility in treating young patients. However, since the use of drugs and/or treatments is not supported by clinical trials and little information is available on the Internet, off-label use requires genuine trust of parents in the pediatric ophthalmologist.
Without off-label use, the choice of drugs for pediatricians becomes very limited. For example, in China, where there are stringent policies on off-label use, there are very few drugs and medical devices that can be prescribed to children.
Many popular procedures that have shown good results in adults are still uncommon in pediatric groups. Astigmatic keratotomy, a popular procedure to correct astigmatism in adults, either in isolation or in conjunction with cataract surgery, is still not a common procedure in China and other Asian countries. Furthermore, the response to this procedure in pediatric age groups may be different from that of adult groups. As a result, pediatric ophthalmologists have no nomogram for reference, making it even more difficult to popularize the procedure. More clinical trials and research studies on popular procedures in adults are warranted in pediatric patients so we can have more data to support or oppose the procedures instead of standing behind empty claims.
Femtosecond laser-assisted cataract surgery has yielded good clinical results in adults. This may be applicable to pediatric cataract cases, because making a round and intact capsulotomy with appropriate size and centration can increase the successful rate of implanting an IOL in the capsular bag, which is a key issue to pediatric cataract surgery. However, pediatric ophthalmologists have differing opinions on the implantation of multifocal IOLs in their patients, and with limited pediatric data, it is not easy to decide on whether these lenses should be used in a pediatric population.
This is also the case regarding the use of anti-VEGFs for treating retinal vascular anomalies in children. The use of anti-VEGF for the treatment of age-related macular degeneration in adult patients is well-established. Although the treatment is theoretically feasible in children, lack of clinical data in this population makes it more difficult to convince parents to allow their children to receive the treatment.
Increased education needed
While pediatric patients should be given the chance to receive proper treatments, pediatric ophthalmologists often hesitate to prescribe the treatment modules used in adults with similar diseases. And even if pediatric ophthalmologists did choose to run the risk of prescribing such treatments, parents are still often hesitant to consent to the treatments due to the lack of well-established data. Therefore, both pediatric ophthalmologists and patients’ family members should be educated to be more open-minded and less timid in choosing treatment for children while also keeping the risks in mind.
Although there are a number of emerging technologies in pediatric ophthalmology with good clinical results, it is still not easy to popularize them, for difficulties including lack of customized pediatric products from pharmaceutical companies and limited data-supported clinical trials for off-label use medicine. More clinical and research data will surely help test out the efficacy of these technologies before they are widely used. Hopefully with this supporting information, ophthalmologists and family members can make more informed choice for pediatric patients in the near future.
For more information:
Dennis S.C. Lam, MD, FRCOphth, can be reached at State Key Laboratory in Ophthalmology, Sun Yat-Yen University, 54 South Xianlie Road, Guangzhou 510060, People’s Republic of China; +852-3997-3266; fax +852-3996-8212; email: dennislam.gm@gmail.com.
Disclosure: Prof. Lam has no relevant financial disclosures.