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New ROP guidelines take center stage at AAPOS
Along with finding better postop treatment techniques, this year’s American Association of Pediatric Ophthalmology and Strabismus meeting focused on changing regulations.
KEYSTONE, Colo. — Recently released guidelines for screening infants with retinopathy of prematurity generated much discussion here at the meeting of the American Association for Pediatric Ophthalmology and Strabismus.
Both on and off the podium, the new guidelines had attendees talking about how their current ROP screening practices will be affected.
Jointly promulgated by the American Academy of Ophthalmology, the American Association for Pediatric Ophthalmology and Strabismus and the American Academy of Pediatrics, the guidelines were published in the February issue of Pediatrics.
These issues and others were first published on the OSNSuperSite, as part of the continuing coverage from major meetings. Look for future issue of Ocular Surgery News to feature more in-depth meeting coverage.
Guidelines change ROP screening dates
The main change is that the guidelines now recommend that all infants born between 28 and 32 weeks gestation should be initially screened at 4 weeks after birth. Previously, the guidelines recommended initial screening between 4 and 6 weeks, and the decision was somewhat discretionary depending on considerations such as the local incidence of the disease.
In general, all infants born earlier than 32 weeks gestation and small babies who are born after this gestational mark must be screened for ROP.
For subsequent examinations, the new guidelines outline a screening schedule based on the infant’s gestational and chronologic age to detect ROP before it presents a risk for retinal detachment.
The new guidelines also incorporate the findings of the Early Treatment for Retinopathy of Prematurity Randomized Trial (ETROP), published in Archives of Ophthalmology in December 2003. The ETROP study found significant advantages to early, aggressive treatment of high-risk, pre-threshold ROP.
While many practitioners have already adopted the ETROP findings on their own, the new guidelines in effect codify them, making them standard of care.
Both the revised and original guidelines can be found in their entirety on Pediatrics’ Web site, http://pediatrics.aappublications.org.
The subject generated some controversy during a round table discussion organized by Ocular Surgery News during the AAPOS meeting. Look for this as well as complete coverage of the guidelines’ implications in upcoming issues of Ocular Surgery News.
Take ‘ownership’ of ROP patients, speaker says
Pediatric ophthalmologists must overcome their apprehension and take “ownership of care” when it comes to treating babies with ROP, according to a pioneer in the field.
To confront the high-risk nature of ROP, specialists must accept complete responsibility for these patients “from birth through maturity,” said Earl A. Palmer, MD, FAAP, who gave the Frank D. Costenbader Lecture.
ROP management should be viewed as a single encounter with a patient, but on an extended time scale, Dr. Palmer suggested.
“I would like to persuade you today that there is no more reason to fear ROP care, but it requires us to take ownership of care,” Dr. Palmer said. “Just as the microsurgeon keeps an eye on the surgical field, so then do we – on a much longer time scale – need to accept responsibility to monitor the [premature baby’s] fundi throughout this protracted encounter.”
Dr. Palmer said the factor of time is closely tied to effective management of ROP, lending it a dynamic and challenging nature. The disease is most aggressive within the first few months of the premature infant’s life, although the sequence of events varies from patient to patient.
While much has been learned in the past few decades about how to manage the disease surgically, he said, clinical data are conspicuously lacking. Dr. Palmer said he and other leaders, including AAPOS president Michael X. Repka, MD, are calling for the start of randomized clinical trials to study the management of retinal detachments associated with ROP.
“The past 20 years have brought important progress in our attempts to surgically blunt the effects of ROP, but until medical methods appear that deal with retinal detachment, we must renew our efforts to push back the veils of uncertainty that still obscure our own understanding of best practices,” Dr. Palmer said.
He called for a randomized, prospective clinical trial that would include patients with stage 4-A ROP, for whom it is unclear whether observation or immediate intervention is the better approach.
“[Such a study] would trigger a sequence of treatments by stages, each with defined selection criteria,” he said. “The results would inform us of the value of current vitreoretinal surgeries and offer evidence to provide a basis of managing these cases.”
Dr. Palmer also addressed the new ROP screening guidelines published in the February issue of Pediatrics.
These guidelines, he said, “have changed our standard of care as rapidly as the Cryo-ROP study,” he said, referring to the landmark multicenter study published in 1988 that investigated the use of cryotherapy in patients with ROP. Dr. Palmer is perhaps best known as the organizer of that study.
While “attorneys will be paying attention” to the new guidelines in terms of their effect on malpractice issues, physicians who are meticulous in their follow-up and who are “redundant” in communicating risk to parents should be safe, Dr. Palmer said.
Congressman outlines proposed changes to U.S. health system
Turning patients into health care “consumers” will create more responsible patients and will allow them to have better relationships with their physicians, according to Rep. Pete Sessions.
Mr. Sessions, a Republican from Texas, was a special guest speaker who told the audience that he feels a personal connection with pediatric ophthalmology, as father to one son with ocular problems related to Down syndrome and another son who was diagnosed with retinitis pigmentosa at age 16.
Mr. Sessions discussed congressional efforts under way in Washington to change the direction of health care in the 21st century. He said the current Congress is nearly evenly divided over whether there should be a single-payer system or a free market for medical services in the United States.
Mr. Sessions said he sides with those who believe in a free market system in which patients will be able to pay out of pocket for services. To accomplish this, some advocates in Congress, along with the Bush Administration, are seeking to establish health savings accounts, he said.
These accounts would enable all Americans – not just those with corporate jobs – to purchase health care services on a pre-tax basis so they can pay in cash at the time a medical service is rendered.
“[Patients] will be able to come to you, write you a check on a cash basis for what you do, and you will not have to fight the insurance companies,” Mr. Sessions said.
Another initiative pending in Washington would have hospitals list their services along with the upper end of the price range for those services, so that patients would know exactly what they are getting and how much they could expect to pay.
“Many hospitals are spending much too much time justifying what they charge,” Mr. Sessions said.
He argued that this proposed bill would ensure fairer rates for everyone and would reinstate a sense of trust between patient and doctor.
Both initiatives, he said, are geared to turn patients into “consumers,” and to make them more personally responsible for ensuring the quality of their own care.
He urged ophthalmologists to “find a way to get to know your members of Congress” and work to continually improve the practice of medicine.
“What is at risk here is something that should be solved and should not go by the wayside,” he said.
Surgical techniques
Lens extraction holds promise, remains controversial, in highly myopic children
Refractive lensectomy can be an effective option for a select group of children with high anisometropic myopia who are noncompliant with contact lens or spectacle use, according to a surgeon.
Asim Ali, MD, presented the results of a small retrospective study here at the AAPOS meeting.
Dr. Ali and colleagues looked at seven patients with anisometric-myopic amblyopia with a mean age of 9 years at the time of surgery. Those included had myopia of at least –12 D in addition to spectacle or contact lens intolerance. These patients also were absent any ocular disorders that would preclude intraocular surgery, such as glaucoma, uveitis or endothelial cell dysfunction. The ability to follow up with these patients for postoperative care was also important, Dr. Ali said.
Patients either underwent lensectomy alone, combined lensectomy/vitrectomy or lensectomy/vitrectomy with IOL implantation, Dr. Ali said. Five patients were left aphakic and two were implanted with a phakic IOL.
There were two males and five females, with a mean preoperative error of –16.7 D (range of –12 D to –24.5 D) in the operated eye.
Five of the seven patients had a preoperative visual acuity of worse than 20/800, Dr. Ali said. The axial length averaged 4.4 mm longer in the operated eye than the fellow eye, he noted. All patients had strabismus, and most were exotropic.
The mean visual change was 17.3 D, Dr. Ali noted. Six of the seven eyes were corrected to within 3 D of the goal refraction, and the seventh eye was within 4 D of the goal.
Two patients had to undergo Nd:YAG laser capsulotomy after surgery due to complications, including one patient who had postoperative hyphema in an eye that had been previously treated for stage 4-A ROP.
Dr. Ali said he and colleagues concluded that the procedure was highly effective in terms of correcting ametropia, and did not cause any sight threatening complications in the study eyes. He cautioned that the procedure should be considered for a select group of patients only and that the family must understand the risks.
Alternatives to the approach, he said, include excimer laser procedures or phakic IOLs, which are also limited by the degree of myopia that can be treated, corneal thickness, or the depth of the anterior chamber.
In a followup discussion to Dr. Ali’s presentation, Arlene V. Drack, MD, stressed the need to approach these results with caution. She said it is important to keep in mind the long-term risk of retinal detachment in highly myopic eyes, and posed the question of whether this risk is lessened by the use of phakic IOLs, rather than lens extraction.
“The big question is: does clear lens extraction benefit the patient?” Dr. Drack said. “The authors said it improved visual function, but there were no data presented to support what the functional improvement was.”
She called for future studies of this nature to include quality of life measures and better visual function data. Furthermore, she pointed out that one of the seven patients was functionally monocular, a fact not reported by Dr. Ali during the presentation and one that is contrary to the study’s title: Unilateral lens extraction for high anisometropic myopia.
She said the paper is important in that “the authors extended our knowledge of refractive surgery in children,” but called for more data on visual function in the patients, as well as prospective data and quality of life measures in future studies.
Early surgery for infantile esotropia shows promise, study finds
Children with infantile esotropia who underwent surgery before 6 months of age were found to have a higher prevalence of fusion and stereopsis than those who underwent surgery later, according to a presenter.
The proper timing of surgery for this condition has been a controversial subject for which there have been no conclusive data, Eileen E. Birch, PhD, said.
Previous studies reporting promising sensory outcomes from early surgery have been limited by sample sizes of fewer than 20 patients, she noted.
She and her colleagues enrolled a total of 128 children in their study. Of these children, 50 had early surgery (between 2.5 to 5.5 months of age) and 78 had standard surgery between 6 to 12 months of age. Patients were followed from 4 to 17 years, Dr. Birch said.
Factors evaluated during follow up included angle of deviation, subsequent surgeries, postoperative treatment with spectacles, amblyopia, fusion and stereopsis, she said.
The early surgery group had more patients with peripheral fusion, central fusion and stereopsis, Dr. Birch said. This group also had 20% of patients achieving random dot stereoacuity of 200 seconds or better, compared to about 9% in the later surgery group.
While the early surgery group overall fared better in these categories, Dr. Birch said the fact that only 38% achieved stereopsis and 20% scored well on the random dot test was worth noting.
“The question that rose in my mind was: Did some patients already have sufficient abnormal visual experience to preclude rehabilitation?” she asked.
Dr. Birch noted that concerns about angle instability measurement inaccuracy did not appear to present a problem.
There was no statistically significant difference between the two groups in terms of dissociated vertical displacement or final amblyopia, Dr. Birch said. Both groups also had similar rates of additional surgery and postoperative spectacle use, she added.
Tetracaine may ease pain, mental distress postop
Pediatric patients with strabismus who received topical tetracaine ophthalmic drops before and after surgery experienced less pain and postoperative agitation than those who received saline drops, according to William Anninger, MD.
Dr. Anninger and colleagues found that applying tetracaine 1% improved postoperative pain as well as emergence agitation, which refers to mental disturbances following anesthesia including hallucinations, confusion, moaning, delusions and involuntary physical activity.
The investigators hypothesized that emergence agitation leads to parental and medical team dissatisfaction and increased time spent in the recovery room. The symptoms are related to pain and, therefore, should be relievable with effective pain relief, they said.
Dr. Anninger enrolled 88 patients scheduled for strabismus surgery, aged 1 to 12 years, in a double-masked, controlled trial. The patients were randomized to one of three groups: patients who received saline drops before and after surgery (Group A); patients who received tetracaine 1% before surgery and saline drops after surgery (Group B); and those who received tetracaine 1% before and after surgery (Group C).
Nurses observed the patients in the post-anesthesia care unit using two scales: a behavior scale and a modified behavioral pain scale.
Using the behavior scale, a higher percentage of patients in Group A exhibited behaviors associated with emergence agitation, while patients in the tetracaine groups tended to be more calm or asleep, Dr. Anninger said.
Under the modified behavioral pain scale, patients were assessed a score of zero to 10 for their facial expression, level of crying and bodily movements. Patients who received scores of five or greater were considered to be in severe pain and those who scored seven or higher received morphine.
“A higher percentage of patients in groups B and C received scores of less than five, at 5, 10 and 30 minutes,” Dr. Anninger said.
He noted there was not a statistically significant difference between the groups in terms of total recovery room time, vomiting, morphine use or pain experienced at home.
Also, applying tetracaine before and after surgery displayed no clear benefit over applying it postoperatively alone, he said.
Dr. Anninger said he found the use of tetracaine to be simple, inexpensive and time efficient. His said his group incorporated it into their routine at the Children’s Hospital of Philadelphia.
Blue-light filtering IOL less compatible
A blue-light filtering IOL was found to be generally well tolerated in children in a study, although significant inflammation occurred in some cases, according to one of the researchers in the study.
David R. Stager Jr., MD, evaluated the Alcon AcrySof Natural IOL in the treatment of pediatric aphakia.
“The question we wanted to answer was, Does [the AcrySof Natural] maintain the biocompatibility of its predecessors [in children]?” Dr. Stager said. By “predecessors,” he meant previous models in Alcon’s AcrySof acrylic IOL line without the yellow chromophore that lends the Natural its blue-light filtering properties.
Dr. Stager and colleagues conducted a retrospective review of 38 eyes of 30 patients implanted with the lens, aged 1 month to 13 years. They collected data including cataract type, age, type of surgery and postoperative course, paying particular attention to postoperative inflammation. Eyes with coexisting ocular pathology were excluded.
There were no postoperative complications in about 60% of eyes, Dr. Stager said. In about 40% of eyes, significant amounts of postoperative inflammation were observed, including fibrinous membranes on the optic, posterior synechiae, significant cell and flare, and rapid development and recurrence of posterior capsular opacification.
Patients with these complications were treated with systemic and topical steroids and cycloplegic agents. A lens was explanted from one eye due to the presence of inflammatory membranes, Dr. Stager said.
“Our data suggest that there exists a higher incidence of inflammatory events with the [AcrySof] Natural IOL compared with [previous AcrySof models],” he said.
He noted that these findings are puzzling because the lens is chemically similar to other AcrySof models. The key question, according to Dr. Stager, is whether these events were caused by the yellow chromophore or by other confounding factors such as packaging or contamination.
“These results are suggestive and not conclusive,” he said, adding that the study was limited by its retrospective nature.
Aphakic, pseudophakic children best suited for ECP
Endoscopic cyclophotocoagulation produced better outcomes in aphakic and pseudophakic children than in children with other glaucoma etiologies, according to B. Christian Carter, MD.
Dr. Carter said previous studies conducted by his group have found the success rate of endoscopic cyclophotocoagulation (ECP) to range from 43% to 50%, depending on which study was referenced. Dr. Carter and colleagues wanted to single out the aphakic and pseudophakic subpopulations to see what their success rates would be.
“Aphakic glaucoma is a very common disease after extraction of congenital cataract,” Dr. Carter said. “The incidence can be about 35%, and is primarily an open angle disease.”
Dr. Carter and colleagues studied 34 eyes of 25 patients, the majority of which were aphakic. Patients whose aphakia was related to congenital glaucoma were excluded from the study, as well as those with anterior segment dysgenesis.
ECP was performed with the Microprobe (Endo Optiks) integrated laser endoscope system. Patients were followed for a minimum of 12 months, or until treatment failure was declared. Failure was defined as patients with IOP greater than 24 mm Hg, despite the use of medication, or the need for any further intervention that was not ECP, Dr. Carter said. The development of any visually threatening complications was also considered failure, he added.
The study found a 59% overall success rate, with a mean of 1.5 treatments per eye.
The mean baseline IOP was just under 32 mm Hg and mean follow up was 44 months, he said.
The mean age at the time of surgery was just over 4 years old. For more than 80% of the eyes in the study, ECP was the first intervention to lower IOP. Sixty two percent of eyes underwent a single treatment, and 38% underwent multiple treatments. In the single-treatment group, there was a 67% success rate.
Medications were not greatly affected by the interventions, he noted. Over half the treatment successes (55%) required no postoperative glaucoma medication.
Out of 52 total procedures, there were two vision-threatening complications from retinal detachment. There was no evidence of hypotony in any patient, despite nearly 25% of the patients receiving 360° of laser treatment.
Dr. Carter said the good results and low complication rate indicate that aphakic and pseudophakic patients might be “the subgroup best suited for this intervention.”
“The 59% overall success rate is greater than what we have previously attained with endolaser when applied to various other etiologies of pediatric glaucoma,” he said.