Pediatric standard of care changing rapidly as new guidelines emerge

In a report from the OSN Section Editor Summit, Robert S. Gold, MD, discusses how pediatric eye specialists need to stay informed of new studies, legislation and guidelines that affect clinical practice.

There are many changes taking place in the pediatrics arena that practitioners must continually assimilate into their practices, some occurring for good reasons and others for not-so-good reasons.

Some of the current issues that will have a large impact on how we practice include the Infant Aphakia Treatment Study, retinopathy of prematurity (ROP) screening guidelines, the work of the Pediatric Eye Disease Investigator Group, refractive surgery in children and pediatric vision screening.

The Infant Aphakia Treatment Study (IATS), which began in December 2004, seeks to enroll a total of 96 patients by May 2008. To be eligible, patients must be less than 7 months old with a congenital unilateral cataract. After obtaining parental consent, patients are randomized to receive either a contact lens or IOL.

The coordinator of this study is Scott Lambert, MD, of Emory University in Atlanta. There are 12 centers throughout the United States, all of which are actively recruiting patients. This study will be important in determining whether it is appropriate to implant IOLs in infants, and to understand the complications and benefits of this procedure.

Changes in ROP screening

Robert S. Gold

Another controversial issue, screening for retinopathy of prematurity (ROP), is an ever-changing and risky subject for pediatric ophthalmologists and retina specialists alike.

A policy statement was published in the February 2006 issue of Pediatrics, updating a statement published 5 years earlier, titled “Screening Examination of Premature Infants for Retinopathy of Prematurity.”

At the core of the revision is that infants are eligible for screening if they weighed less than 1,500 g at birth or were born at less than 32 weeks’ gestation. Selected infants between 1,500 g and 2,000 g, or those born past 32 weeks’ gestation who have an unstable clinical course, are on cardiorespiratory support or have been designated as high-risk cases by the neonatologist also should be screened, according to the guidelines.

Pediatric ophthalmologists are urged to be much more conservative than ever, and the guidelines seek to cover all the bases.

The guidelines also recommend the use of topical anesthetics for exams in all infants, in addition to other types of sedation including pacifiers or oral sucrose.

Obviously, the use of topical anesthetics for every infant is increasing our costs somewhat. In the past I have not used them routinely, but with these recommendations, if an infant happens to have a problem and you do not use an anesthetic, you could have a problem.

Another important take-home point from the revised screening guidelines is the following quote:

“Retinal examinations in preterm infants should be performed by an ophthalmologist who has sufficient knowledge and experience to enable accurate identification of the location and sequential retinal changes of ROP.”

It is incumbent upon all pediatric ophthalmologists who screen these patients, and the retina specialists who treat them, that they be up-to-date with the latest guidelines. If they are not, they are leaving themselves vulnerable to legal trouble.

Taking adequate precautions

There is an increased awareness today that we are responsible for communicating with the parents at every step and for providing appropriate documentation of our discussions with them.

The new screening recommendations, say the responsibility for the examination and follow-up of infants with ROP must be carefully defined by each neonatal intensive care unit (NICU). With the standard of care for ROP changing at a rapid pace, every practitioner must know exactly what protocol to follow at a time when there is great medicolegal risk for pediatric ophthalmologists and retina specialists.

There have been some large medicolegal suits involving ROP screening that have frightened many of those who screen. It is a concern that we live with every day.

The key to staying ahead is tracking infant patients. In my office I have a specific ROP coordinator who takes charge of tracking every infant I see and following up with the parents.

If the parents and children do not show up for an appointment, we send them certified letters and place a phone call to the Department of Children and Families in our state. It is up to us to find these people and make sure they come in; if we do not, we are unfortunately held accountable.

Pediatric Eye Disease Investigator Group

The Pediatric Eye Disease Investigator Group (PEDIG) is a group of pediatric ophthalmologists throughout the country conducting research sponsored by the National Eye Institute. There are many studies going on simultaneously in this group, many of which have been reported by Ocular Surgery News.

The studies in progress include one comparing patching vs. atropine for amblyopia therapy in patients aged 7 to 13, another comparing atropine vs. a combination of atropine plus a lens for patients aged 3 to 7 years, and a study looking at near vs. distance activities for amblyopic patients undergoing patching therapy.

Studies by this group that have completed enrollment and are currently in the follow-up phase pertain to long-term treatment for amblyopia, treatment of amblyopia in older children aged 7 to 18, and the effects of 2 hours of daily patching in children aged 3 to 7.

The bilateral refractive amblyopia treatment study, led by Michael X. Repka, MD, is also under way under the PEDIG umbrella. That study will enroll 100 patients.

The studies that have been done by the PEDIG investigators have already begun to alter the way we treat amblyopia. I treat patients differently than I did 5 years ago because I am constantly evaluating and instituting new recommendations from this group. Additionally, my patient compliance has shot up dramatically, and I am noticing better results in patients. Having applied the new recommendations to my clinical situations, I can see that they are working for me.

Refractive surgery

These days we are asked all the time by 9-year-olds, 14-year-olds, 16-year-olds and their parents when a patient is old enough for refractive surgery.

LASIK and PRK have been used in small numbers of pediatric patients for anisometropic amblyopia as an alternative to glasses or contact lenses, especially in noncompliant patients. But it is unclear as to the safety of refractive surgery in pediatric populations because only a few studies have been published.

Vision screening

The issue of vision screening is not going away. As a matter of fact, until recently it has gotten continually more intense as the battle has heated up between ophthalmologists and optometrists over the best manner to identify vision problems in young children.

But in a surprising and hopeful development, ophthalmic and optometric organizations have now joined together to support the same bill, recently introduced in the U.S. Senate. For the first time, the American Academy of Ophthalmology, and American Academy of Pediatric Ophthalmology and Strabismus, the American Optometric Association and the Vision Council of America are all supporting the same piece of legislation.

The proposed legislation would fund vision care for children who fail preschool vision screenings or eye exams through block grants from the federal government to the states. (See related article.)

This is a landmark bill, and it may mark a change in the traditional battle lines on the issue of vision care for young children.

Traditionally, medical groups such as the AAO and AAPOS have supported screenings to identify vision problems in young children. Optometric groups such as the American Academy of Optometry have not seen the value of these screenings, and instead have advocated that all babies under the age of 1 should have a comprehensive eye exam.

The medical and ophthalmology groups’ position has been that comprehensive eye exams would be extremely costly and a waste of resources, arguing instead that periodic vision screening is an appropriate and effective tool for detecting problems as the eye develops.

For more information:

• Robert S. Gold, MD, is Pediatrics/Strabismus Section Editor for Ocular Surgery News. He can be reached at 225 W. State Road 434, Suite 111, Longwood, FL 32750; 407-767-6411; fax: 407-767-8160; e-mail: rsgeye@aol.com.